July 16, 1997 97-29 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT Various chocolate candy: a) Assorted Chocolates, 18 ounces b) Assorted Chocolates, 12 ounces c) Assorted Chocolates, 6 ounces d) Coconut Cream Eggs, 8 ounces, 16 ounces, 2 pounds, 5 pounds e) Butter Cream Eggs, 8 ounces, 16 ounces, 2 pounds, 5 pounds f) Chocolate Fudge Eggs, 8 ounces, 16 ounces, 2 pounds, 5 pounds Recall #F-495/500-7. CODE (These are Macy's product identification codes. There are NO manufacturing codes): (1) "Macy's Traditional American Chocolates", 18 ounces, coded: EGO601 (2) "Macy's" Assorted Chocolates, 12 ounces, coded EGO603 (3) "Macy's" Assorted Chocolates, 6 ounces, coded EGO602 (4) Coconut Cream Eggs, 8 ounces, coded EGO604 16 ounces, coded EGO605, 2 pounds, coded, EGO606, 5 pounds, coded EGO607 (5) Butter Cream Eggs, 8 ounces, coded EGO604 16 ounces, coded EGO605, 2 pounds, coded EGO606, 5 pounds, coded EGO607 (6) Chocolate Fudge Eggs, 8 ounces, coded EGO604, 16 ounces, coded EGO605 (No 2 pounds or 5 pounds sized eggs of this type were sold.) MANUFACTURER Bayard-Prete Candy Company, Inc., Pennsauken, New Jersey. RECALLED BY Manufacturer, by letters on March 5 and 13, 1997, and by press release on March 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION New Jersey, Georgia, New York, Connecticut, Massachusetts, Rhode Island, Pennsylvania, Delaware, Virginia, Florida, Louisiana. QUANTITY Amount distributed: (1) Macy's Traditional American Chocolates: 18 oz, 792 units (12X66cs) (2) Macy's 6 ounces assorted chocolates: 480 units (24X20cs) (3) Macy's 12 oz assorted chocolates: 98 units (14X7 cs) (4) Coconut Cream Eggs: 8 ounces : 1104 eggs (24X46 cs) 16 ounces : 960 eggs (12X80 cs) 2 pounds : 12 eggs (4X3 cs) 5 pounds : 4 eggs (2X2 cs) (5) Butter Cream Eggs: 8 ounces : 960 eggs (24X40 cs) 16 ounces : 480 eggs (12X40 cs) 2 pounds : 12 eggs (4X3 cs) 5 pounds : 4 eggs (2X2 cs) (6) Chocolate Fudge Eggs: 8 ounces : 480 eggs (24X20 cs) 16 ounces : 144 eggs (12X12 cs). REASON The products did not bear full ingredient statements and contained the following undeclared ingredients that could elicit reactions in sensitive individuals: a) brazil nuts, cashews, walnuts, peanuts, peanut butter, egg albumen, whole milk, almonds, and sulfites b) and c) peanuts, peanut butter, egg albumen, whole milk, and sulfites d) egg albumen, whole milk, FD&C Yellow 6, and sulfites e), and f) egg albumen, whole milk, and FD&C Yellow 6. _______________ PRODUCT Sarabeth's Kitchen's Peach-Apricot Preserves, in 9 ounce and 18 ounce glass jars. Recall #F-501-7. -2-CODE All codes/lots manufactured prior to 12/11/96. MANUFACTURER S.B.K. Preserves, Inc., doing business as Sarabeth's Kitchen, New York, New York. RECALLED BY Manufacturer, by letter on April 18, 1997, and by press release. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. Firm estimates little if any product remain on the market. REASON Product contains undeclared sulfites. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Turkish Delight Akide Candy, in 12 ounce rigid tubs, a hard candy. Recall #F-488-7. CODE None. All product containing the unapproved color additive Ponceau 4R. MANUFACTURER Capaloglu Vokosu, Istanbul, Turkey. RECALLED BY EFE, Inc., Brooklyn, New York, by letter on January 21, 1997. Completed recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and Georgia. QUANTITY 18 containers were distributed. Firm estimated that little, if any product remain on market. REASON Product contained the unapproved color additive Ponceau 4R. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Minute Maid Berry Juice in 64 ounce gable-top cartons. Recall #F-492-7. CODE Container: JUN 18 LEY XXXX and JUN 19 LEY XXXX - Shipping Case: XXXX LEY JUN18 W12774C BERRY PUNCH 2739 and XXXX LEY JUN19 W12774D BERRY PUNCH 2739. MANUFACTURER Cutrale Citrus Juices USA, Leesburg, Florida. RECALLED BY The Minute Maid Company, Houston, Texas, by hand held computers on May 16, 1997, and by visits on May 16 and 22, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 6,668 cases were distributed. REASON The product is adulterated due to the presence of CS-400, a hi-strength, chelated liquid alkali system used for circulation cleaning throughout the food industry. -3-_______________ PRODUCT Sarabeth's Kitchen Preserves, in 9 ounce and 18 ounce glass jars: a) orange-Apricot Marmalade; b) Apricadabra; c) Lemon-Pear Butter. Recall #F-502/504-7. CODE (a&b) All codes/lots manufactured prior to 12/11/96; c) All codes/lots manufactured prior to 4/4/97. MANUFACTURER S.B.K. Preserves, Inc., doing business as Sarabeth's Kitchen, New York, New York. RECALLED BY Manufacturer, by letter sent on April 18, 1997, and by press release. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. Firm estimated little if any product remain on market. REASON Products contain undeclared sulfites. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Liquefied Carbon Dioxide, Bulk. Recall #F-491-7. CODE Production dates involved are 02/03/97 - 02/17/97. No production codes are used with the product. Production is continuous and storage of the finished product is commingled within the bulk storage system used. Any product shipped to customers constitutes a mix of residual carbon dioxide produced on that date as well as all previous dates. MANUFACTURER Praxair, Inc., Loudon, Tennessee. RECALLED BY Manufacturer, by telephone and letter beginning on February 18, 1997, and ending February 26, 1997. Firm-initiated field correction complete. DISTRIBUTION Tennessee, Kentucky, Florida, Virginia, Pennsylvania, New York. QUANTITY Undetermined. REASON Product was contaminated with low levels of carbonyl sulfide. _______________ PRODUCT Sarabeth's Kitchen Blood Orange Marmalade, in 9 ounce and 18 ounce glass jars. Recall #F-505-7. CODE All codes/lots manufactured prior to April 4, 1997. Firm-initiated recall ongoing. MANUFACTURER S.B.K. Preserves, Inc., doing business as Sarabeth's Kitchen, New York, New York. RECALLED BY Manufacturer, by letter sent on April 18, 1997, and by press release. Firm-initiated recall ongoing. -4-DISTRIBUTION Nationwide. QUANTITY Undetermined. Firm estimates little if any product remain on the market. REASON Product contains undeclared sulfites. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Lithobid (Lithium Carbonate extended release tablets, 300 mg, packaged in bottles of 100 and 1000, Rx used for the treatment of depression and bipolar disease. Recall #D-217-7. CODE Lot numbers: 86864 (100s) and 86848 (1000s). MANUFACTURER Solvay Pharmaceuticals, Baudett, Minnesota. RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia, by telephone on April 17, 1997 and by letter on May 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 13,917 100-tablet bottles and 1,432 1000-tablet bottles were distributed. REASON Dissolution failure (stability). _______________ PRODUCT Phenylhistine Expectorant, Antitussive- Decongestant Expectorant, each 5 ml contains: Codeine Phosphate (10 mg.), Pseudoephedrine Hydrochloride (30 mg.), Guaifenesin (100 mg.) and Alcohol (7.5%) in bottles of 4 fluid ounces and 16 fluid ounces, packaged under the Vintage and Qualitest labels. Recall #D-223-7. CODE Lot No. 012J6, EXP 10/98 (Qualitest/Vintage), 012J6A, 012J6B, 012J6C, 012J6D, 012J6E. MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, Alabama. RECALLED BY Manufacturer, by telephone followed by letter dated May 9, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 8,149 4-fluid ounce bottles and 5,766 16-fluid ounce bottles were distributed. REASON Product lacks stability for the Codeine Phosphate ingredient with the six (6) month assay falling below specification (subpotent). _______________ PRODUCT Sterile Saline 0.9%, For Irrigation purposes only, 110 mL, in prefilled graduates, Rx. Recall #D-224-7. -5-CODE Catalog No. 5501: 4 lot numbers: 7775, 7804, 7806, 7813; Catalog No. 5501R: 3 lots numbers: 7805, 7807, 7814. Expiration Date 7/99 for the above 7 lots. MANUFACTURER Intermed/Allstate, A Division of Urohealth Systems, Inc., Sparta, New Jersey. RECALLED BY Manufacturer, by fax on or about September 12, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 2,386 cases (84,192 vials) were distributed. REASON Labeling error -- Some units of sterile saline were labeled as sterile water. _______________ PRODUCT Lithium Carbonate Tablets, USP, 300 mg, packaged in bottles of 100, Rx prescribed as remedial and/or maintenance drug therapy for the treatment of individuals diagnosed with manic episodes characterizing Bipolar Disorders. Recall #D-225-7. CODE Lot #961458 EXP 6/1/98. MANUFACTURER Roxane Laboratories, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by letter on June 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,455 bottles were distributed; firm estimated that 20% of product remained on market at time of recall initiation. REASON Product fails dissolution specification (stability). _______________ PRODUCT Histalet Forte Tablets, antihistamine-decongestant(Phenylpropanolamine HCl 50 mg/Pyrilamine Maleate 25 mg/Phenylephrine HCl 10 mg/Chlorpheniramine Maleate 4 mg), packaged in 20, 100 and 250 tablet bottles. Recall #D-226-7. CODE Lot numbers: F960551A - 250 tablet bottles F960551B - 100 tablet bottles X960778A - 20 tablet bottles ** X960778B - 250 tablet bottles X960778C - 100 tablet bottles **repackaged into bottles of 100's. MANUFACTURER Mikart, Inc., Atlanta, Georgia. RECALLED BY Manufacturer, by letter on May 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arizona, California, Florida, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Oklahoma, Texas. -6-QUANTITY Lot F960551A - 376 bottles were shipped Lot F960551B - 3727 bottles were shipped Lot X960778A - 9919 bottles were shipped Lot X960778B - 259 bottles were shipped Lot X960778C - 2160 bottles were shipped. REASON Product failed content uniformity (validation). _______________ PRODUCT 1% Lidocaine HCl Injection, USP, 10 mg/ml, 50 ml multiple dose vials held in shelf packs of 25 vials, Rx SVP for production of local or regional anesthesia. Recall #D-227-7. CODE Lot #23-198-DK. MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina. RECALLED BY Abbott Laboratories, Hospital Products Division, Abbott Park, Illinois, by letter dated June 26, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and The Netherlands. QUANTITY 180,250 vials were distributed; firm estimated that 20% of product remained on the market at time of recall initiation. REASON Mispackaged -- Correctly labeled 2% vial packaged in 1% labeled shelf pack. ________________ PRODUCT Acetaminophen Tablets, 325 mg, OTC analgesic, in 100 tablet plastic bottles. Recall #D-229-7. CODE Lot #100166 EXP 4/98. MANUFACTURER AAA Pharmaceutical, Inc., Paulsboro, New Jersey. RECALLED BY Manufacturer, by telephone and fax on March 28, 1997. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 649 bottles were distributed; firm estimates none remains on the market. REASON Labeling -- Incorrect lot number. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Corneal Tissues for Transplant: Corneal Human Tissue. Recall #B-750-7. CODE Donor numbers: 93-4437/8, 93-4441/4, 93-4449, 93-4451, 93-4453/6, 93-4463, 93-4465/6, 93-4469/70, 93-4473/6, 93-4479, 93-4483/90, 93-4493/8, 93-4501/2, 93-4507, 93-4509, 93-4511/3, 93-4515/6, 93-4520, 93-4523/32, -7- 93-4537/40, 93-4543/4, 93-4546, 93-4549/52, 93-4557/62, 93-4567/70, 93-4572, 93-4577/82 and unit numbers 94-0021/0022, 96-1563/1564. MANUFACTURER Lions Eye Bank of Texas, Baylor College of Medicine, Houston, Texas. RECALLED BY Manufacturer, by letter dated April 8, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY All recalled product has been transplanted and none remains in stock. REASON Human Tissues for Transplant which: Were not tested for HIV-2; Donor's corneas tested repeat reactive for anti-HIV-1/2; One donor's blood may have been hemodiluted during viral marker testing. _______________ PRODUCT Platelets. Recall #B-880-7. CODE Unit #16LR10733. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of Whole Blood with an extended collection time. _______________ PRODUCT Platelets, Pheresis. Recall #B-993-7. CODE Unit #4501025. MANUFACTURER Carter Blood Center, Fort Worth, Texas. RECALLED BY Manufacturer, by telephone on May 28, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-1000-7. CODE Unit #LH02831. MANUFACTURER Irwin Memorial Blood Centers, San Francisco, California. RECALLED BY Manufacturer, by letter dated February 17, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with an unacceptable hematocrit. -8-_______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1002/1003-7. CODE Unit #1293480. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated December 12, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-1004-7. CODE Unit #11316-1302. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 5, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Platelets. Recall #B-1005-7. CODE Unit #5025918. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on September 27, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-1006-7. CODE Unit #732277. MANUFACTURER Community Blood Center, Dayton, Ohio. RECALLED BY Manufacturer, by letter dated February 18, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. -9-_______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1007/1008-7. CODE Unit numbers: 5010831, 5014851, 5027455. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on January 3, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1009/1010-7. CODE Unit #2004042. MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio. RECALLED BY Manufacturer, by telephone on October 8, 1996, and by letter dated November 25, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-1011/1012-7. CODE Unit #M90301. MANUFACTURER Topeka Blood Bank, Inc., doing business as Kansas Blood Services, Topeka, Kansas. RECALLED BY Manufacturer, by telephone on March 28, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri and Kansas. QUANTITY 1 unit of each component was distributed. REASON Blood products with an elevated ALT result were labeled as negative. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1016/1017-7. CODE Unit #11314-6490. MANUFACTURER United Blood Services, El Paso, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 5, 1997. Firm-initiated recall complete. DISTRIBUTION Texas and New Mexico. QUANTITY 1 unit of each component was distributed. REASON Blood products were prepared from a unit of Whole Blood designated as overweight. -10-_______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-1018/1019-7. CODE Unit numbers: a) 1258143; b) 1258143 and 1273695. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on December 16 and 23, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY a) 1 unit; b) 2 units were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1029/1030-7. CODE Unit #42H98740. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated May 27, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was taking the drug Proscar. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1031/1032-7. CODE Unit #42G02452. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letters dated December 23 and 18, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was taking the drug Zovirax. _______________ PRODUCT Platelets. Recall #B-1033-7. CODE Unit #49F97919. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by telephone on May 2, 1997, followed by letter dated May 5, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. -11-REASON Blood product corresponded to a unit of Red Blood Cells that was reported as clotted. _______________ UPDATE Recall #B-886/888-7, Red Blood Cells; Platelets; Plasma, which appeared in the June 11, 1997 Enforcement Report is being rescinded. Information included in this recall is identified as Recall #B-616/618-6. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-997/999-7. CODE Unit #24KK71562. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated April 11, 1997. Firm-initiated recall complete. DISTRIBUTION Kentucky and Indiana. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking an experimental CMV vaccine. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1021/1022-7. CODE Unit numbers: a) 1007028, 1018619, 1018623; b) 1005271, 1007028. MANUFACTURER Community Blood Center, Dayton, Ohio. RECALLED BY Manufacturer, by letter dated February 25, 1997 or April 1, 1997, and March 18, 1997, and April 28, 1997. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY a) 3 units; b) 2 units were distributed. REASON Blood products were collected in expired collection bags. _______________ PRODUCT Red Blood Cells. Recall #B-1037-7. CODE Unit numbers: 40GV09619, 40GV09620, 40GV09621, 40GV09622, 40GV09623, 40GV09624, 40GV09625, 40GV09626, 40GV09627, 40GV09628, 40GV09629, 40GV09630, 40GV09631, 40GV09632, 40GV09633, 40GV09634, 40GV09635, 40GV09636, 40GV09637, 40GV09639. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 2, 1997, and by letter dated June 13, 1997. Firm-initiated recall complete. -12-DISTRIBUTION Illinois, Missouri, Tennessee, California, Pennsylvania. QUANTITY 20 units were distributed. REASON Blood products were stored at an unacceptable temperature. _______________ UPDATE Recall #B-781/782-7, Streptokinase Kabikinase, a sterile purified preparation of bacterial protein elaborated by group C B-hemolytic streptococci, which appeared in the June 4, 1997, Enforcement Report is being updated as follows: a) Streptokinase Kabikinase 250,000 IU, lot 14476A51; b) Streptokinase Kabikinase 1,500,000IU, lot 14304A51. Additional information from the firm indicates portions of these lots were labeled MANUFACTURED BY: Kabi Pharm., Inc., Uppsala, Sweden DISTRIBUTED BY: Kabi Pharm., Inc., Pischataway, New Jersey. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Microaire Pulse Lavage Tube Sets and Pulse Lavage Hip Sets, used with the Pulse Lavage Handpiece 4740-000, a precision instrument for debriding bone surfaces as well as cleansing trauma and other soft tissue wounds. Recall #Z-705/708-7. CODE Product Number Lot Number a) 4740-060 129624156 4740-060 019724464 4740-060 029725355 b) 4740-061 119623581 4740-061 119623582 4740-061 119623583 4740-061 019724833 4740-061 029724834 4740-061 029725487, 039725776 c) 4740-062 119623858 4740-062 129623048 4740-062 129624155 4740-062 129624395 4740-062 019724465 4740-062 039725707 d) 5600-70 DePuy Lot N0. R98AK4000 DePUY Product MicroAire Lot No. 019724466. MANUFACTURER Microaire Surgical Instruments, Charlottesville, Virginia. RECALLED BY Manufacturer, by letters dated April 15 and 28, 1997. Firm-initiated recall ongoing. -13-DISTRIBUTION Nationwide and international. QUANTITY 1,389 tubing set units and 197 hip set units were distributed. REASON The devices are subject to separation at the joint between the nose connection and the pump body of the product which could result in the nozzle falling into the surgical field. _______________ PRODUCT Anesthesia Gas Sampling Tee Connector, Part No. 92002, and Anesthesia Circuits which Contain the Gas Sampling Tee Connector: a) Ohmeda brand Gas Sampling Straight Tee (Plastic); b) SpaceLabs Medical brand TRU-LINK DISPOSABLE ANESTHETIC AGENT SAMPLE LINE WITH GAS SAMPLING TEE for use with 90518 Multigas Analyzer; c) SpaceLabs Medical brand TRU-LINK DISPOSABLE ANESTHETIC AGENT SAMPLE LINE WITH GAS SAMPLING TEE for use with 90518 Multigas Analyzer; d) Gibeck brand Gas Sampling e) Gibeck brand Gas Sampling f) Gibeck brand Mass Spec Straight Tee g) Gibeck brand Gas Sampling Tee h) Gibeck brand Adult Anesthesia Breathing Circuit i) Gibeck brand Pediatric Anesthesia Breathing Circuit j) Gibeck brand Adult Anesthesia Breathing Circuit k) Gibeck brand Gas Sampling Tee with Luer l) Gibeck brand Pediatric Anesthesia Breathing Circuit m) Gibeck brand Adult Anesthesia Breathing Circuit n) Gibeck brand Mass Spec Tee w/Cap Put Label (Criticare) o) Gibeck brand Gas Sampling Tee & Cap Put Label (Datex). Recall #Z-711/725-7. CODE a) Product No. 6027-0000-019; Lot No. M027794. b) Product 015-0312-00; Lot No. M027658. c) Product No. 015-0313-00; Lot No. M027659. d) Product No. 126213-BQW; Lot No. M028791. e) Product No. 12820, Lot Nos. M029039, P003583, and P003612. f) Product No. 12820B; Lot No. M027901. g) Product No. 12820-150, Lot Nos. MO28219 and M028360. h) Product No. 16303-742; Lot Nos. C033964, C034071, C034157, and C034247. i) Product No. 16511-742; Lot No. C034073. j) Product No. 173232-BPG; Lot No. C033735. -14- k) Product 24432; Lot No. M028809. l) Product 304-0002-710; Lots No. C034015 and C034262. m) Product No.304-0001-724; Lot Nos. C034229, C034032, and C034401. n) Product No. 41439B001; Lot No. M027488. o) Product No. 73385; Lot No. M028990. MANUFACTURER Gibeck, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by letter on April 21, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 53,800 connectors were distributed. REASON The gas sampling tee connector was observed to be partially occluded by a thin molded membrane inside the connector. _______________ UPDATE Recall #Z-452/453-7, Sonoline Prima and Versa Pro Ultrasound Systems with Enhanced OB Calculation Package Option, which appeared in the May 7, 1997 Enforcement Report has been extended to include the firms issuance of a second letter alerting users of additional software errors (erroneous onscreen growth curve information). -15- END OF ENFORCEMENT REPORT FOR JULY 16, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for