May 17, 2000 00-20RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT White and Parboiled Rice identified and labeled in part as follows: a) AC Humko Rice Specialties, Long Grain Parboiled Rice, 1800 lbs.; U.S.A. No. 1, Long Grain Parboiled Rice, 45 kgs.; Bedessee's Marque Guyanese Pride brand Demarrara Style Marque Star Bonnet Brand Long Grain Parboiled Rice, 100 lbs., b) Fiesta, Enriched Parboiled Golden Long Grain Rice, 100, 50, 25 lbs c) Iberia, Extra Fancy Long Grain Enriched Rice, 20 lbs., Calypso A#1, Extra Fancy Long Grain Enriched Rice, 50 kg, Lucky 1, Extra Fancy Long Grain Enriched Rice, 50 kg, Alberto A No. 1, Extra Fancy Long Grain Enriched Rice, 100, 50, 20 lbs., Fiesta, Enriched Extra Fancy Long Grain Rice, 50 lbs., 100, Enriched Extra Fancy Long Grain Rice, 100 lbs., d) Tiger Patna, White Natural Long Grain Rice, 40 kg, Mich Asie Excellent Patna Clic, White Natural Long Grain Rice, 40 kg, e) ACH AC Humko 100, Extra Fancy Long Grain Rice, 100, 50, 25 lbs., 6&6 Brand, Extra Fancy Long Grain Rice, 100 lbs., f) Calypso Gold A#1, Long Grain Enriched Parboiled Rice, 50 lbs. Frosy Acres, Enriched Long Grain Parboiled Rice, 50, 25 lbs., g) Frosty Acres, Extra Long Grain Rice, 50, 25 lbs., Canilla, Extra Long Grain Rice, 100, 20 lbs., Frosty Acres 103, Extra Long Grain Rice, 50 lbs., h) Canilla, Extra Long Grain Enriched Rice, 100 lbs., Lucky Brand, Extra Long Grain Enriched Rice, 100 lbs., i) Zatarain's, Enriched Natural Parboiled Extra Long Grain Rice, 100 lbs., China Doll, Enriched Long Grain Rice, 32 oz., j) Fiesta Parboiled Golden Long Grain Rice, 20 lbs. Recall #F-439/449-0. CODE 042G0, 045G0, 046G0, 047G0, 048G0, 049G0, 050G0, 052G0, 053G0, 054G0, 055GO, 056G0, 059G0, 060G0, 061GO, 062G0, and 063G0. MANUFACTURER AC Humko Rice Specialties, Greenville, Mississippi. RECALLED BY Manufacturer, by letter, April 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION New Jersey, New York, Texas, Illinois, Virginia, Florida, Georgia, North Carolina, Massachusetts, Louisiana, South Carolina, Missouri, California, Tennessee, Ohio, Puerto Rico, Canada, Yemen. QUANTITY 9,415,000 pounds of parboiled and white rice were distributed. REASON The product is contaminated with pieces of wire ranging from 7-12 mm in length, approximately 25 gauge. ________ PRODUCT Fancy Fruit Mix in 20-oz. plastic containers, 12 containers per shipping box. Recall #F-450-0. CODE 0800. MANUFACTURER Tropical Nut & Fruit, Inc., Columbus, Ohio. RECALLED BY Manufacturer, telephone on April 13, 2000, and letter faxed on April 14, 2000. Ongoing field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Ohio, Pennsylvania, West Virginia. QUANTITY 6,240 units were distributed. REASON The Dried Fruit Mix contains undeclared FD&C Yellow No. 6. ________ PRODUCT Sweet Creations Hard Candy Flavoring, Chocolate Flavoring, in 1/2-ounce bottles. Recall #F-452-0. CODE None. MANUFACTURER Sweet Creations, Bountiful, Utah. RECALLED BY Manufacturer, by letter on February 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 288 bottles were distributed; firm estimated that less than 25 percent remained on market at time of recall initiation. REASON Chocolate hard candy flavoring contains undeclared FD&C Yellow No. 5, Yellow No. 6, Red No. 40 and Blue No. 1.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Daffinís Candies, in 1-pound containers, 28 individual chocolate covered cherries per container. Recall #F-451-0. CODE None. All product manufactured since 9/99. MANUFACTURER Daffinís Candies, Inc., Farrell, Pennsylvania. RECALLED BY Manufacturer, by placing a corrected adhesive label on products. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Pennsylvania and Ohio. QUANTITY Firm estimated that 500 boxes remained on market at time of recall initiation. REASON Product contains undeclared FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Various sterile skin preparations: a) Clinipad Alcohol Prep, Antiseptic. NDC #19154-1245-3. b) Clinipad Alcohol Prep. NDC #19154-1245-8 c) Cliniswab Iodophar PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick. NDC #19154-1241-2 d) Cliniswab Iodophar PVP Scrub Povidone Iodine USP 3 Saturated Swabsticks. NDC #19154-1242-7 e) Cliniswab Isoprophyl Alcohol Antiseptic, 1 Saturated Swabstick. NDC #19154-1245-9 f) Cliniswab Iodophar PVP Scrub, Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick. NDC #19154-1242-9 g) Cliniswab Iodophar PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks. NDC #19154-1241-3 h) Cliniswab Iodophor PVP Antiseptic Cleanser, Povidone 10% USP, 3 Saturated Swabsticks. NDC #19154-1241-0 i) Clinipad Iodophor-PVP, Povidone-Iodine USP, Titratable Iodine 1% Solution, Antispetic 1 fluid ounce (30 ml). NDC #19154-1241-4 j) Clinidine Povidone Iodine 1% USP Solution Topical Anti- Infective, 1 fluid ounce (30ml). NDC #19154-1241-5 k) Clinidine Povidone Iodine 10% USP Solution Antiseptic Cleanser, 3/4 fluid ounce (30ml). NDC #19154-1241-7. l) Clinidine Ointment Povidone USP Titratable Iodine 1% Antiseptic Germicide net weight .033 ounce (1.0g). NDC #19154-4341-4 m) Clinipad Iodophor PVP Povidone Iodine USP 1 Prep Pad. NDC #19154-1241-1. Recall #D- 325/337-0. CODE Clinipad Reorder Code Lot No. Product Code a) 0110 806610 0110 0110BS 802270 0110BS b) 0250R 716313 0250R c) 1241S-B 812304, 811612 1261S 1261S 812467 HK1241S HK1241S 919882 1241S-B d) HK1244S 919862 HK1244S e) 1251S-B 805817 1251S-B f) 1262S 920324, 918333 810014, 812302 1262S g) 1291S-B 715786, 812873 129S-B HK1291S 911485, 919827 HK1291S h) 1291SK 919249 1291SK i) 3941S-BC 812422 3941S-BC HK3941S 812891, 911939 HK3941S j) 3943S-B 917141 3943S-B k) 3944S-B 919888 3944S-B l) 4339SC 811937, 920315 4339SC HK4339S 919864, 812893 HK4339S m) 9153SBD 812556, 919526 HK9153S HK9153S 919915 9153SBD. MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. RECALLED BY The Clinipad Corporation, Rocky Hill, Connecticut, by letters beginning March 10, 2000. Firm-initiated recall ongoing. See also FDA press release P00-7, March 10, 2000. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Microbial contamination. ________ PRODUCT Herbal dietary supplements in oral dose capsules: a) Diabetes Hypoglucose Capsules,OTC, 70 capsules per bottle; b) Pearl Hypoglycemic Capsules, 60 capsules per bottle. Recall #D-338/339-0. CODE All lot codes. MANUFACTURER a) Pingchuan Group*Pingchuan International Economic Trade Harbin, China; b) Tongyi Tang Pharmaceutical, Harbin, China. RECALLED BY Chinese Angel Health Products, Inc., Blaine, Washington (responsible firm), by letter dated February 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) Approximately 2,139 bottles; b) Approximately 535 bottles were distributed. REASON Misbranding - Product contains the undeclared antidiabetic prescription drug glyburide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Various Nonsterile Skin Preparations: 1) CLINIPAD Acetone Alcohol Prep, 1 Prep Pad, 100 units/folding box, 10 boxes/case and 8,000/case. NDC #NDC 19154-1247-2 2) CLINISWAB Iodophor-PVP Scrub, Povidone-Iodine USP, 3 Saturated Swabsticks/unit, 25 units/folding box; 10 boxes/case 2490SW. NDC 19154-1242-2 3) CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes, Antiseptic, 1000/case. NDC 19154-9152-6 4) CLINIPAD Isopropyl Alcohol 70%, 1 fl. oz. (30 ml), 50 units/folding box; 4 boxes/case and 200 units/case. NDC 19154-1245-5 5) Clinipad Alcohol Prep, 200 units/folding box, 10 boxes/case. NDC #19154-0110-2 6) Clinipad Alcohol Swab, 200 units/folding box, 10 boxes/case. NDC #19154-0110-2 7) Cliniswab Lemon Glycerin, 3 Saturated Swabsticks/unit, 25 units/folding box, 10 boxes/case/. 8) Cliniswab Benzalkonium Chloride, 3 Saturated Swabsticks/unit, 25 units/folding box, 10 boxes/case. NDC #19154-3912-2 9) Cliniswab Benzalkonium Chloride, 3 Saturated swabsticks/unit, 500 units/case. NDC #19154-3911-1 10) Cliniswab Tincture of Green Soap, 1 Saturated Swabstick, 50 units/folding box, 10 boxes/case. NDC #19154-1235-1 11) Cliniswab Isopropyl Alcohol, 1 and 3 Saturated Swabsticks/unit, 25 units/folding box, 10 boxes/case and 50 units/folding box, 10 boxes/case. NDC #19154-1245-1 and 19154- 1245-6. 12) Cliniswab Povidone-Iodine USP, 1 Saturated Swabstick/unit, 50 units/folding box, 10 boxes/case. NDC #19154-9153-2 13) Cliniswab Iodophor-PVP Scrub, Povidone-Iodine USP, 1 Saturated Swabstick/unit, 50 units/folding box, 10 boxes/case. NDC #19154-1242-1 14) Cliniswab Iodophor, Poloxamer-Iodine Complex, 3 Saturated Swabsticks/unit, 25 units/folding box, 10 boxes/case. NDC #19154-9152-3 15) Cliniswab Iodophor-PVP Povidoone-Iodine, 3 Saturated Swabsticks/ unit, 25 units/folding box, 10 boxes/case. NDC #19154-9153-3. 16) Clinipad Antiseptic, 1 Towelette, 100 units/folding box, 10 boxes/case and 2,500 units/case. NDC #19154-3912-3 17) Clinipad Iodophor, Poloxamer-Iodine Complex, 3 Towelettes, Antiseptic, 100/case. NDC #19154-9152-6 18) Clinidine Povidone Iodine USP Solution, 1 fluid ounce (30ml), 50 units/folding box, 4 boxes/case. NDC #19154-9153-4 19) Clinidine Ointment, 0.33 ounce (1.0g), 250 units/folding box, 4 boxes/case. NDC #19154-4341-2 20) Clinidine Solution, Povidone Iodine, 1 Gal. (3.78L), 16 fl. oz. (473 ml), 8 fl. oz. (237 ml), 4 fl. oz. (118 ml), 2 fl. oz. (59 ml), 1 fl. oz. (30 ml). NDC 19154-9153-6, NDC 19154-9153-7, NDC 19154-9153-5 NDC 19154-4444-0, NDC 19154-4444-1, NDC 19154-4444-9 NDC 19154-4445-1 21) Cliniscrub Surgical Scrub, Povidone Iodine, 1 gallon (3.78L), 4 fluid ounces (118ml), 2 fluid ounces (50ml), 50 units/case. NDC #19154-4471-4, NDC #19154-4471-6, NDC #19154-4474-1 22) Clinipad Iodophor PVD, Povidone Iodine USP, 1 Prep Pad, 200 units/folding box, 10 boxes/case. NDC #19154-9153-1 23) Moore Medical, Povidone Iodine USP Antiseptic Swabstick, Reorder #08485, 50 units/folding box, 10 boxes/case. NDC #00839-8074-04 24) Randex Hemmorrhoidal Wipes, 900 units/case and 100 units/case folding box, 10 boxes/case. NDC #19154-3912-9 25) Bidette Cloth Towelettes, 100 units/folding box, 10 boxes/case. NDC (n/a) 26) Vionex Antimicrobial Skin Wipe Towelette (Metrex MX-1510), 50 units/folding box, 10 boxes case. NDC #55443-0102-1 27) E-Z-Prep, 1 Winged Sponge, Iodophor Scrub Solution, 50 units/case. NDC #19154-0310-1 28) E-Z Prep, 2.8" Sponge Sticks Povidone-Iodine Topical Solution, 70 units/case. NDC #19154-1480-1 29) E-Z-Prep, 4 Winged Sponges, Iodophor Scrub Solution, 50 units/case. NDC #19154-0311-5 30) E-Z Prep Solo-Prep Topical Gel, 115 units/case. NDC #19154-1459-1 31) Clinidine Solution, Povidone Iodine, 4-fluid ounces (118ml), and 2-fluid ounces (59ml), 50 units/case. NDC #19154-4444-1 and NDC #19154-4444-9 32) E-Z-Prep Scrub Solution, 4-fluid ounces (118ml), 115 units/case. NDC #19154-0311-4. 33) E-Z-Prep Paint Solution, 2.7-fluid ounces (80ml), 115 units/case. NDC #19154-1460-2. Recall #D-264-296-0. CODE Clinipad Reorder Cod Lot No. 1) 0310, 0310SB All lots 2) 1244 All lots 3) 2490SW All lots 4) 3925, 3925D, 3925B All lots 5) 0610 920842 6) 0610E 913380 7) 1225 905197, 917536, 913121, 914355 8) 1230, 1230CRB 806552, 813702, 814648 9) 1230BK 807004, 810660, 904181 10) 1235 914805 11) 1245, 1251 715480, 912553, 913661, 914449 12) 1261 913244, 914953, 921951 13) 1262 806550, 913512 14) 1290 914080 15) 1291 912164, 914485, 914962, 921451, 921714 16) 2395, 2395B3 811478, 910288, 911943, 911955, 913496, 921469, 911206 17) 2490SW All lots 18) 3941 912129, 912448, 914594 19) 4339 916825 20) 4441, 4442, 4443 813184, 913558, 914231, 915916, 4448, 4444, 4444-D 914730, 914478, 807340, 809320, 4446, 4447 913256, 914477, 904783, 808772 21) 4474, 4474-SC 915508, 810288, 916829, 913556 4476, 4471 915421, 915940, 912322, 809454 HK4474 914965 22) 9153 903940, 911636, 911803, 911804, 914127, 920843, 921206, 921456, 913648 23) 93469 913663, 914568 24) 94526, 99619 911275, 911631, 901844, 911272, 912201, 912441, 912985, 913688 25) 99270 913597 26) 99528, 99533 911283, 912850, 913598, 903193 27) 372211 913565 28) HK0593 911734 29) HK0595 919941 30) HK1570 913554 31) HK4444, HK4446 813557, 809427, 807342 32) HK1629 914451 33) HK1630 912323. MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. RECALLED BY The Clinipad Corporation, Rocky Hill, Connecticut, by letters beginning March 10, 2000. Firm-initiated recall ongoing. See also FDA press release P00-07, March 10, 2000. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Lack of assurance product meets microbial release specifications. ________ PRODUCT 1. CLINIPAD Alcohol Prep, Antiseptic. NDC #19154-1245-3. Except lot #806610-Product code 0110 tc "Except lot #806610-Product code 0110 " \l 2 #802270 0110BS tc " #802270 0110BS " \l 2 2) CLINIPAD Alcohol Prep, Antiseptic. NDC #19154-1245-8 Except Lot # 716313-Product code 0250R tc "Except Lot # 716313-Product code 0250R " \l 2 3) Moore Medical Corp. Alcohol Prep Pad 70% Isopropyl Alcohol Medium 2 Ply. NDC #00839- 8072-06, Reoroder No. 30839 Box/200 Reorder No. 08481 Box/100 4) CLINIPAD Acetone Alcohol Prep, 1 Prep Pad. NDC #19154-1245-7 5) Steri Wipe 1 Alcohol Swab. NDC #19154-1245-7 6) Rauscher Alcotupf Alkoholtupfer Tampons alcoolises Alcohol wabs REF ALKT. NDC (n/a) 7) CLINISWAB Compound Benzoin Tincture Topical Protectant, 1 Saturated Swabstick. NDC #19154-1231-2 8) CLINIGUARD Protective Dressing, 1 Saturated Swabstick. NDC (n/a) 9) CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick. NDC #19154-1241-2 Except Lot # 812304, 811612-Product code 1261S tc "Except Lot # 812304, 811612-Product code 1261S " \l 2 # 812467 HK1241S # 919882 1241S-B 10) CLINISWAB Iodine Tincture, 2% U.S.P. Topical Anti-Infective, 1 Saturated Swabstick. NDC #19154-1243-3 11) CLINISWAB Iodophor PVP Scrub Povidone Iodine USP 3 Saturated Swabsticks. NDC #19154- 1242-7 Except Lot # 919862-Product code HK1244S tc "Except Lot # 919862-Product code HK1244S D-307-0 " \l 2 12) CLINISWAB Isopropyl Alcohol Antiseptic, 3 Saturated Swabsticks. NDC #19154-1245-0 13) CLINISWAB Acetone Alcohol Topical Anti-Infective, 1 Saturated Swabstick. NDC #19154- 1247-3 14) CLINISWAB Acetone Alcohol Topical Anti-Infective, 3 Saturated Swabsticks. NDC #19154-1247-5 15) CLINISWAB Isopropyl Alcohol Antiseptic, 1 Saturated Swabstick. NDC #19154-1245-9 Except Lot # 805817-Product code 1251S-B tc "Except Lot # 805817-Product code 1251S-B " \l 2 16) CLINISWAB Iodophor PVP Scrub, Povidone Iodine USP, Antiseptic, 1 Saturated Swabstick. NDC #19154-1242-9 Except Lot # 920324, 918333, 810014, 812302-Product code 1262S tc "Except Lot # 920324, 918333, 810014, 812302-Product code 1262S " \l 2 17) CLINISWAB Iodophor PVP Povidone Iodine USP, Antiseptic, 3 Saturated Swabsticks. NDC #19154-1241-3 Except Lot # 715786, 812873-Product code 1291S-B tc "Except Lot # 715786, 812873-Product code 1291S-B " \l 2 # 911485, 919827-Product code HK1291S tc " # 911485, 919827-Product code HK1291S " \l 2 18) CLINISWAB Iodophor PVP Antiseptic Cleanser, Povidone Iodine 10% USP, 3 Saturated Swabsticks. NDC #19154-1241-0 Except Lot # 919249-Product code 1291SK tc "Except Lot # 919249-Product code 1291SK " \l 2 19) EZ PREP 220 Povidone Iodine (Minimum Available Iodine 0.5%) 2-8" SpongeSticks. NDC #19154-1462-1 20) CLINIPAD IODOPHOR-PVP, Povidone-Iodine USP,Titratable Iodine 1%, Solution, Antiseptic 1 fl.oz (30ml.). NDC #19154-1241-4 Except Lot # 812422 Product code 3941S-BC # 812891, 911939, Product code HK3941S tc " # 812891,911939, -----------Product code HK3941S " \l 2 21) CLINIDINE Povidone Iodine 1% USP Solution Topical Anti-Infective, 1 fl. oz (30 ml). NDC #19154-1241-5 Except Lot # 917141-Product code 3943S-B. 22) CLINIDINE Povidone Iodine 10% USP Solution Antiseptic Cleanser, 3/4 fl. oz (21ml). NDC #19154-1241-7. Except Lot # 919888-Product code 3944S-B 23) CLINIDINE OINTMENT Povidone Iodine USP Titratable Iodine 1% Antiseptic Germicide Net WT.033 oz. (1.0g). NDC #19154-4341-4 Except Lot # 811937, 920315-Product code 4339SC. 919864, 812893-Product code HK4339S tc " 919864, 812893-Product code HK4339S " \l 2 24) CLINIGUARD Protective Dressing Prep, 1 Prep Pad. NDC # (n/a) 25) CLINIPAD Iodophor PVP Povidone Iodine USP 1 Prep Pad. NDC #19154-1241-1 Except Lot tc "Except Lot " \l 2 # 812556, 919526 Product code HK9153S # 919915 Product code 9153SBD tc " # 919915 ------Product code 9153SBD " \l 2 26) CLINIPAD Iodophor, Poloxamer-Iodine Complex, 3 Towelettes, Antiseptic. NDC #19154- 9152-9 27) CLINIPAD Snapsule PVP Iodine Solution 10% USP Swab Applicator Net 0.67 ml Product No.9151S. NDC #19154-1241-9 28) Cooper Instrument Corporation Antibacterial Probe Wipes Single Use Packet. NDC (n/a) Recall #D-324-0. CODE All codes except where noted above. Clinipad Reorder Numbers: 1) 0110 0110B3 0110BS 0110CRB 0110M 0110R 0110T 0110TA 99510 99512 HK0110 90110 2) 0250B 0250R 3) 0110H HK0110H 4) 0310S-B HK0310S 5) 0510 0510B 0510-BT 93461 6) 0610ER-RAU 7) 1231S-B HK1231S 8) 1233S-B HK1233S 9) 1241S-B 1261S HK1241S 10) 1243S-B HK1243S 11) 1244S-B HK1244S 12) 1245S-B HK1245S 13) 1247S-B HK1247S 14) 1248S-B HK1248S 15) 1251S-B HK1251S 16) 1262S 17) 1291S-B HK1291S 18) 1291SK 1291SKB 19) 372201 3941S-B 20) 3941S-BC HK3941S 21) 3943S-B 22) 3944S-B 23) 4339S-B 4339SC HK4339S 24) 8133S-B HK8133S 25) 9153S-B 9153-SBD HK9153S 26) HK2490S 27) HK9151S 28) 99529. MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. RECALLED BY Clinipad Corporation, Rocky Hill, Connecticut, by letters beginning March 10, 2000. Firm-initiated recall ongoing. See also FDA press Release P00-7, March 10, 2000. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Lack of assurance for sterility.RECALLS AND FIELD CORRECTIONS: BIOLOGICS-- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-480-0. CODE Unit #50LJ09396. MANUFACTURER American Red Cross Blood Services, Toledo Ohio. RECALLED BY Manufacturer, by telephone on October 21, 1999, and by fax on October 25, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Arava. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Fresh Frozen Plasma. Recall #B-588/590-0. CODE Unit Numbers: a) 50F65387, 50F73585, 50F19157, 50FG06830, 50J47190, 50G20515, 50J38230, 50F77310, 50F09658, 50F94240, 50F79185 b) 50G20515; c) 50F65387, 50F73585, 50F19157, 50FG06830, 50J47190, 50J38230, 50F05462, 50F77310, 50F09658, 50F94240, 50F79185. MANUFACTURER American Red Cross Blood Services, Toledo, Ohio. RECALLED BY Manufacturer, by letters dated October 21, 22, 25, 27, 28, 1999/or November 18, 1999, and December 10, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio, Illinois, Alabama, Massachusetts, Arkansas, Tennessee, California. QUANTITY a) 11 units; b) 1 unit; c) 11 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-603/604-0. CODE Unit Numbers: a) 21KH22705, 21KK03558, 21Y50418, 21KG02152, 21GJ64276; b) 21KH22705, 21Y50418, 21KG02152, and 21GJ64276. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on September 21, 1999, followed by letters dated September 29, 1999 and November 5, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, California, Oregon, Washington state, Oklahoma. QUANTITY a) 5 units; b) 4 units were distributed. REASON The blood products were collected from a donor taking the drug Zovirax. __________ PRODUCT Red Blood Cells, Frozen Plasma. Recall #B-605/606-0. CODE Unit #29FM22863. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated September 13 and 21, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina and Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who previously tested repeatedly reactive for anti-HIV. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-607-0. CODE Unit #C02374. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on February 5, 2000, and by letter dated February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose suitability was not adequately determined. ________ PRODUCTS Platelets. Recall #B-608-0. CODE Unit #L01829. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on February 5, 2000, and by letter dated February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose suitability was not adequately determined. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-609/610-0. CODE Unit #T52088. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on February 5, 2000, and by letter dated February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose suitability was not adequately determined. ________ PRODUCT Platelets, Pheresis, Irradiated. Recall #B-612-0. CODE Unit #29FP61279. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated December 30, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was mislabeled as CMV antibody negative. ________ PRODUCT Recovered Plasma. Recall #B-615-0. CODE Unit #29FC60013. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by forwarding a "Questionable Plasma Inquiry" to the California consignee on November 16, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma. Recall #B-616/617-0. CODE Unit #29KZ02684. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer a) by letter dated November 12, 1999; b) by forwarding a "Questionable Plasma Inquiry" to the California consignee on November 16, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma. Recall #B-618/619-0. CODE Unit #29FS79924. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated December 21, 1999, January 21, 2000 and February 18, 2000, and by forwarding a "Questionable Plasma Inquiry" to the California consignee on December 28, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis A. ________ PRODUCT Recovered Plasma. Recall #B-620-0. CODE Unit #1167692. MANUFACTURER Long Island Blood Services, A Division of New York Blood Center, Inc., Millville, New York. RECALLED BY New York Blood Services [Center West], A Division of New York Blood Center, Inc., New York, New York, by fax on November 29, 1999, December 17, 1999, and January 10, 2000. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Proscar. ________ PRODUCT Red Blood Cells. Recall #B-621-0. CODE Unit #29GV35782. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated January 10, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Zovirax. ________ PRODUCT Carticel (Autologous Cultured Chondrocytes). Recall #B-622-0. CODE Lot #C81713. MANUFACTURER Genzyme ñ Tissue Repair, Cambridge, Massachusetts. RECALLED BY Manufacturer, by telephone on January 10 and 12, 2000, and by letter dated February 1, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 2 vials were distributed. REASON Tissue repair product was contaminated with Staphylococcus epidermis. ________ PRODUCT Platelets. Recall #B-624-0. CODE Unit #24KY35576. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by telephone on February 4, 2000, and by letters dated February 14, 2000 and March 8, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana. REASON Blood product was collected from a donor taking the drug Piroxicam. _______ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-642/643-0. CODE Unit Numbers: a) 21KH15621, 21GJ98979, 21GY24752; b) 21GJ98979. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letters dated December 1, 1999, and January 10, 2000. Firm-initiated recall complete. DISTRIBUTION California, Oregon, Washington state. QUANTITY a) 3 units; b) 1 unit. REASON Blood products were collected from a donor who reported previously testing repeatedly reactive for anti-HCV. ________ PRODUCT Red Blood Cells. Recall #B-644-0. CODE Unit Numbers: 21GC74661, 21GC74691, 21GC74983. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on November 21, 1999. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 3 units were distributed. REASON Blood products were not leukoreduced were distributed labeled as leukoreduced. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipated AHF; c) Recovered Plasma. Recall #B-645/647-0. CODE Unit #21KH21928. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on June 30, 1999, by letter dated December 23, 1999, and by fax on December 22, 1999. Firm-initiated recall complete. DISTRIBUTION California and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported previously testing positive for hepatitis C. ________ PRODUCT Source Plasma. Recall #B-648-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Serex International, Inc., Van Nuys, California. RECALLED BY Manufacturer, by letter dated January 26, 2000, February 11 and 16, 2000, and March 2, 2000. Firm-initiated recall complete. DISTRIBUTION California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania, Utah, Virginia, Canada, Germany and Sweden. QUANTITY Approximately 20,703 units were distributed. REASON Blood products were collected from donors with a history of sex with another male or intravenous (IV) drug use. ________ PRODUCT Recovered Plasma. Recall #B-649-0. CODE Unit #01KX36736. MANUFACTURER American Red Cross Blood Services, West Henrietta, New York. RECALLED BY Manufacturer, by letter dated May 14, 1999. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with Multiple Sclerosis. ________ PRODUCT Red Blood Cells, Recovered Plasma. Recall #B-650/651-0. CODE Unit #21FM34769. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 14, 2000, and by fax on January 4, 2000. Firm- initiated recall complete. DISTRIBUTION Oregon, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who previously tested positive for hepatitis C.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Recovered Plasma. Recall #B-481-0. CODE Unit #50LJ09396. MANUFACTURER American Red Cross Blood Services, Toledo, Ohio. RECALLED BY Manufacturer, by fax on October 25, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug, Arava. ________ PRODUCT Platelets, Irradiated. Recall #B-611-0. CODE Unit #S02285. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on January 6, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose arm inspection had not been documented. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-613-0. CODE Unit #1491890. MANUFACTURER New York Blood Services [Center West], A division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated January 10, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cell, Irradiated. Recall #B-614-0. CODE Unit Numbers: 1523905 and 1523926. MANUFACTURER Long Island Blood Services, A Division of New York Blood Center, Inc., Millville, New York. RECALLED BY New York Blood Services [Center West], A Division of New York Blood Center, Inc., New York, New York, by telephone on February 9, 2000 and by letter dated March 1, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-639-0. CODE Unit Numbers: 12440-6573 and 12440-6575. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 10, 1999. Firm- initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Platelets. Recall B-652-0. CODE Unit #21GC80823. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on January 12, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
Medline SPT Surgical and Procedure Kits and Trays containing recalled Clinipad products. Recall #Z-524-0 CODE The affected kits/trays contain the following Clinipad components alone or in combination: Medline/SPT Part # Clinipad Reorder # Description 05766 1245S-B Alcohol Swabstick 3/PK 06235 1247S-B Acetone Alcohol Swabstick 05413 1248S-B Acetone Alcohol Swabstick 07762 3943S-B Clinidine Povidone Iodine CLI1243 1243 Iodine Tincture Swabstick CLI372211 372211 E-Z Prep PVP Wing Sponge CLI4444CD 4444CD Clinidine PVP Sol. 4 oz. CLI4474CD 4474CD Cliniscrub PVP Scrub 4 oz. 00546 1291B Iodorphor PVP Swabstick 3pk 01200 9153B Iodophor PVP Prep Pad 02176 1230B Swabstick BZK 3:1 PK 05160 0250B Alcohol Prep Pad 05165 1241B PVP Swabstick 1/PK 05481 1233B Skin Protectant Swabstick 95488 1251B Alcohol Swabstick 05768 4339B Ointment Iodophor PVP 1 GR 05789 1242B PVP Scrub Swabstick 1/PK 05836 0310B Acetone Alcohol Pad 06070 3925B Isopropyl Alcohol 1 oz. 06233 1231B Compound Benzoin Tincture Swabstick 08990 1244B PVP Scrub Swabstick 3/PK 10096 8133 Skin Protectant Prep Pad (NOTE: If necessary a complete list of kits and part numbers can be obtained from the Chicago District Recall Coordinator). MANUFACTURER Medline Industries, Inc., SPT Division, Waukegan, Illinois. RECALLED BY Medline Industries, Inc., Mundelein, Illinois, by letter dated March 16, 2000, instructing users not to use Clinipad products within kits and Medline sales representatives will visit and apply stickers that state "RECALL Do Not Use The Clinipad Products Within This Kit Destroy The Clinipad Product". Firm-initiated recall ongoing. MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 175,500 kits in commerce by FDA estimate. REASON Kits contain Clinipad antiseptic products that may be contaminated with bacteria. ________ PRODUCT Sterile Surgical and Procedure Kits/Trays distributed under labels identifying: Medikmark Inc., 900 Asbury Drive, Buffalo Grove, IL 60089; Medikmark, Inc., 3600 Bur Wood Drive, Waukegan, IL 60085; Distributed by Maxxim Medical, Case Management Division, Clearwater, FL 34622; Manufactured for R&J Medical Supply, Milwaukee, WI 53223; Distributed by Triad Medical, Laguna Hills, CA 92653. Recall #Z-525-0. CODE One or more of the following Clinipad products were packaged in each of the Medikmark manufactured kits/trays, but the lot numbers of the Clinipad products are unknown: a) 0250B, Clinipad Alcohol Prep b) 0310S-B, Clinipad Acetone Alcohol Prep Pad c) 1251S-B, Cliniswab Isopropyl Alcohol Swabstick d) 1248S-B, Cliniswab Acetone Alcohol Swabtick, 3 swabs e) 0110BS, CliniPad Alcohol Prep f) 1245S-B, Cliniswab Isopropyl Alcohol Swabstick, 3 swabs g) 1230BS h) 1231S-B, Cliniswab Compound Benzoin Tincture Swabstick i) 1233S-B, Cliniguard Protective Dressing Swabstick j) 3943S-B, Clinidine Povidone Iodine 1% USP Solution, 1oz. k) 9153S-B, Clinipad Iodophor PVP Povidone Iodine USP Prep Pad l) 1244S-B, Cliniswab Iodophor PVP Scrub Povidone Iodine USP, 3 Swabsticks m) 1241S-B, Cliniswab Iodophor PVP Povidone Iodine USP, 1 Swabstick n) 1291S-B, Cliniswab Iodophor PVP Povidone Iodine USP, 3 Swabsticks o) 2395B3, Clinipad Antiseptic Towelette p) 3925B, Clinipad Isopropyl Alcohol 70%, 1 oz. q) 4444-D, Clinidine Solution, Povidone Iodine, 4 oz. r) 4446, Clinidine Solution, Povidone Iodine, 2 oz. s) 4474-SC, Cliniscrub Surgical Scrub, Povidone Iodine, 4 oz. t) 4476, Cliniscrub Surgical Scrub, Povidone Iodine, 2 oz. u) 4484 v) HK4444, Clinidine Solution, Povidone Iodine, 4 oz. x) 4338SB All lots of kits/trays manufactured in the last three years are being recalled. (NOTE: If necessary, a complete list of lot numbers can be obtained from the Chicago District Office Recall Coordinator.) MANUFACTURER Medikmark, Inc., Waukegan, Illinois. RECALLED BY Manufacturer, by letter dated March 16, 2000, providing stickers advising users not to use the Clinipad components and to them. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY 1,350,000 kits in commerce FDA estimate. REASON The kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria. ________ PRODUCT Various Sterile Procedure Kits and Trays containing antiseptic products that may be contaminated with bacteria. Recall #Z-603-0. CODE All lots of Clinipad Procedure Kits containing recalled Sterile and Non-Sterile Drug Products- Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, Alcohol, and Sterile Cliniguard Protective Dressing. (NOTE: If necessary, a complete list of all kits/trays (approximately 1,208) can be obtained from the New England District Office Recall Coordinator.) MANUFACTURER Clinipad Corporation, Norwich, Connecticut. RECALLED BY Clinipad Corporation, Rocky Hill, Connecticut, by letters on March 9, 2000(antiseptics) and April 3, 2000, instructing users to apply Warning Stickers provided and to destroy the antiseptics. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,000,000 units. REASON Class I - Antiseptic products may be contaminated with bacteria. Class II - Kits/trays contain products for which the sterility could be assured. Recall has been classified as Class I and II: Kits/trays manufactured and listed with specific lot numbers -- Class I. Kits/Trays not specifically listed with lot numbers, but which contain products for which the sterility could not be assured -- Class II ________ PRODUCT Various sterile procedure kits containing antiseptic products recalled by Clinipad Corporation under the Kendall brand (Curity, Kenguard and Sage); and private label: Allegiance, Source and Respiratory Support Products, Inc. (RSP). Recall #Z-605-0 CODE All lots containing the recalled Clinipad antiseptic Item #3944S-B, Lot #91988 and other Clinipad products. (NOTE: If necessary, a complete detailed list and product codes can be obtained from the New England District Office Recall Coordinator.) MANUFACTURER KenMex, Tijuana, Mexico, Kendall Healthcare, Chatswork, California. RECALLED BY The Kendall Company, LP, Mansfield, Massachusetts, by letter March 24, 2000, providing stickers and advising end users to discard Clinipad antiseptics in kits. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 100,000 cases were distributed. REASON Class I - Kits contain antiseptic products that may be contaminated with bacteria. Class II - Kits contain Clinipad antiseptic products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits manufactured with the recalled antiseptic product (assigned Kendall Lot Numbers 9348004 and 9355014) - Class I Kits not containing those specific lots, but which contain Clinipad products for which the sterility could not be assured - Class IIRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Recall #Z-484-0 which appeared in the April 19, 2000 Enforcement Report should read: PRODUCT: Total B-hCG Controls, for in-vitro diagnostic use.END OF ENFORCEMENT REPORT FOR MAY 17, 2000. ####
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