FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
05/25/1994
Recalls and Field Corrections: Foods -- Class II -- 05/25/1994
May 25, 1994
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT North Pole brand Lime Flavored Sherbet packaged in 4 ounce
plastic cups. Recall #F-396-4.
CODE 003-94 through 065-94.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania, by
letter March 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Firm estimates little, if any, product remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Various flavors of sherbet in 3 gallon bulk containers:
(a) Spumoni; (b) Rainbow Ice Cream; (c) Lime Sherbet;
(d) Rainbow Sherbet. Recall #F-397/400-4.
CODE None.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania, by
letter March 15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Giant Foods brand Orange Soda, in 12 ounce cans.
Recall #F-401-4.
CODE "SELBY022695/CB2****" (the asterisks indicate the military
time of packaging).
MANUFACTURER Concord Beverage Company, Concordville, Pennsylvania.
RECALLED BY Manufacturer, by telephone March 25, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Maryland, Virginia, Washington, D.C.
QUANTITY 2,000 cases were distributed; firm estimates 1,460 cases
remain on the market.
REASON Product contains potassium benzoate that is precipitating out
of solution as benzoic acid.
_______________
PRODUCT Keebler Ripplin's Potato Snack Chips, Original Flavor, in 6
ounce packages. Recall #F-402-4.
CODE SELL BY JUN 28 94.
MANUFACTURER Keebler Company, Haltom City, Texas.
RECALLED BY Keebler Company, Elmhurst, Illinois, by issuing a press
release on April 8, 1994, followed by letter. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,083 cases (12 per package) were distributed.
REASON Product contains undeclared milk products.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
PRODUCT Maple Walnut Ice Cream, in 3 gallon bulk containers.
Recall #F-394-4.
CODE None.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania, by
letter March 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contains undeclared walnuts.
_______________
PRODUCT Peanut Butter and Chocolate Ice Cream, in 3 gallon bulk
containers. Recall #F-395-4.
CODE None.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-point Ice Cream Sales Company, Ambridge, Pennsylvania, by
letter March 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Primatec Compound Tincture Benzoin, USP, in 1 fluid ounce
plastic bottles, nonprescription pharmaceutical.
Recall #D-277-4.
CODE DXM-AD EXP 12/94.
MANUFACTURER Primatec Pharmaceuticals, Inc., West Kingston, Rhode Island
(repacker).
RECALLED BY Repacker, by telephone March 31, 1994. Firm-initiated recall
complete.
DISTRIBUTION New Hampshire.
QUANTITY 1 case of 50 units were distributed.
REASON A portion of the lot contained coal tar topical solution.
_______________
PRODUCT (a) Magnesium Citrate Oral Solution, lemon flavored;
(b) Magnesium Citrate Oral Solution, low sodium, lemon
flavored. Recall #D-278/279-4.
CODE LOT NOS. & EXP DATES BRAND NAMES
3I9852 9-95 Longs, Medic; Phar-Mor; Stop &
Shop; and, Walgreens
3I9866 9-95 Swan Citroma; Full Value; Health
Mart; Home Health Family; Medalist;
OSCO; Shoprite; Suprex; and,
Walgreens
3K9811 10-95 Swan Citroma; Family Pharmacy;
Longs; Medalist; Medic; Phar-Mor;
and, Valu-Rite
3M9809 12-95 Swan Citroma; Dominick's; Family
Pharmacy; Full Value; Home Health
Family; Longs; Medalist; Meijer;
OSCO; Stop & Shop; and, Super Tru
3M9856 12-95 Swan Citroma; and, Walgreens
4A9840 1-96 Swan Citroma; Drug Emporium; Good
Sense; Medalist; Shurfine; and,
Spartan
4A9869 1-96 Eckerd; Rite Aid; and, Top Care
4A9932 1-96 Swan Citroma; Perry Health Care;
Shop 'n Save; Thrifty; and Top
Care
4A9933 1-96 Swan Citroma; K & B; Peoples; and,
Rite Aid
4A9934 1-96 Swan Citroma; CVS; Eckerd; and,
Pathmark
4B9801 2-96 Swan Citroma; Full Value; Health
Mart; Medalist; Medic; OSCO; Super
Tru; and, Walgreens
4B9832 2-96 Swan Citroma; Good Sense; Medic;
OSCO; and, Select brand
4B9834 2-96 Swan Citroma; Eckerd; Furr's; Kare;
Lv Action; Rite Aid; and, Top Care
4B9835 2-96 Swan Citroma; CVS; Peoples; Shop 'n
Save; and, Valu Star
4B9903 2-96 Swan Citroma; Drug Emporium;
Equality; Good Sense; Longs;
Medalist; OSCO; and, Shurfine
4B9904 2-96 Swan Citroma; Fame; Home Health
Family; Shoprite; Spartan;
Valu-Rite; and, Western Family
4B9905 2-96 Swan Citroma; Arbor; Finast; Food
Lion; Pathmark; REVCO; and, Valu
Star
4B9906 2-96 Swan Citroma; Eckerd; Giant Eagle;
K & B; Rite Aid; Top Care; and
Treasury
4B9930E 2-96 Swan Citroma; Dominick's Fred's;
Medalist; and, OSCO;
(b) 3I9862 9-95 Brite-Life; Drug Emporium; and,
Humco
3K9840 10-95 Swan Citroma; Brite-Life; Family
Pharmacy; Humco; and, Shoprite
3K9858 10-95 Swan Citroma; Brite-Life; Humco;
and, Shoprite
3L9879 11-95 Swan Citroma; Brite-Life; Drug
Emporium; and, Humco
4A9828 1-96 Swan Citroma
4A9930 1-96 Brite-Life; Drug Emporium; Family
Pharmacy; Humco; and, Shoprite
4B9907 2-96 Swan Citroma; Drug Emporium; Humco;
Royvac; and, Shoprite.
MANUFACTURER Cumberland-Swan, Inc., Smyrna, Tennessee.
RECALLED BY Manufacturer, by letter April 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY Firm estimated that 65,500 dozen of the regular formula and
24,800 dozen of the low sodium remained in commerce at time
of recall initiation.
REASON Some bottles contained glass particles.
_______________
PRODUCT Levothyroxine Sodium Tablets, 0.5 mg, in bottles of 30, Rx
oral snythetic thyroid hormone. Recall #D-283-4.
CODE Lot #3343074.
MANUFACTURER Chelsea Laboratories Caribe, Inc., Bayamon, Puerto Rico
(responsible firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letter April 27, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois, Florida.
QUANTITY 28 bottles were distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Chlorpromazine HCl Oral Concentrate USP, 100 mg per 3.4 ml,
Rx oral tranquilizer/antiemetic. Recall #D-282-4.
CODE Lot numbers: 302604, 304605.
MANUFACTURER Roxane Laboratories, Columbus, Ohio.
RECALLED BY Xactdose, Inc., South Beloit, Illinois (repacker), by
letters dated May 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 444 cases were distributed; firm estimates 25 percent
remains on the market.
REASON Product does not meet pH specifications.
_______________
PRODUCT Triamcinolone Acetonide Lotion, USP,in 2 fluid ounce
bottles, Rx topical corticosteroid for the relief of the
inflammatory and pruritic manifestations of corticosteroid-
responsive dermatoses:
(a) 0.025%, sold under the following labels:
Pennex, Manufactured by Pennex Pharmaceuticals, Inc., Morton
Grove, IL; PBI, Manufactured by Pharmaceutical Basics, Inc.,
Morton Grove, IL; Qualitest, Manufactured for Qualitest
Products, Inc., Huntsville, AL; Rugby, Manufactured for
Rugby Laboratories, Inc., Rockville Centre, NY; Schein,
Distributed by Schein Pharmaceutical, Inc., Port Washington,
NY;
(b) 0.1%, sold under the following labels:
Pennex, Manufactured by Pennex Pharmaceuticals, Inc., Morton
Grove, IL; PBI, Manufactured by Pharmaceutical Basics, Inc.,
Morton Grove, IL. Recall #D-280/281-4.
CODE Lot numbers: (a) 19768, 19582, 19768, 19823, 2001, 20096,
20153; (b) lot #19473, 19566, 19756, 19813, 20014.
MANUFACTURER Pennex Pharmaceuticals, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter May 16, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 54,636 bottles; (b) 21,769 bottles were distributed;
firm estimates 30 percent of product remains on the market.
REASON Subpotency.
_______________
PRODUCT Betamethasone Valerate USP 0.1% Ointment, in 15 and 45 gram
tubes, Rx topical corticosteroid with anti-inflammatory,
anti-pruritic and vasoconstrictive actions, under the
following labels: NMC, Goldline, Major Quality, Major
Pharmaceuticals, Schein, H.L. Moore. Recall #D-284-4.
CODE Lot #2K926 EXP 5/95.
MANUFACTURER NMC Laboratories, Inc., Glendale, New York.
RECALLED BY Manufacturer, by letter May 17, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,092 45-gram tubes and 8,542 15-gram tubes were
distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-282-4.
CODE Unit #49LG04377.
MANUFACTURER The American National Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone October 27, 1993, followed by
letter November 22, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, that tested indeterminate for the antibody to
human T-lymphotropic virus type I (anti-HTLV-I) by Western
Blot, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-283-4.
CODE Unit numbers: 22FK58314, 22GW23817, 22GW23821, 22GW23824,
22GW23825, 22GW23827.
MANUFACTURER The American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone January 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, New Jersey.
QUANTITY 6 units.
REASON Blood products, corresponding to units of Platelets which
were implicated in a case of post-transfusion septicemia
with coagulase negative Staphylococcus sp., were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Bard 4/5F 65CM and 90CM High Flow Flush Intravascular
Catheters, for use as intravascular diagnostic catheters
used to record hemodynamic pressures:
(a) 006481 4F 65CM Pigtail Pediatric Flush
(b) 006482 4F 65CM Straight Pediatric Flush
(c) 006483 5F 65CM Pigtail Pediatric Flush
(d) 006484 5F 65CM Straight Pediatric Flush
(e) 006664 4F 65CM 8SH Pigtail Flush Catheter
(f) 006665 4F 90CM 8SH Pigtail Flush Catheter
(g) 006666 4F 65CM 8SH Straight Flush Catheter
(h) 006667 4F 90CM 8SH Straight Flush Catheter
(i) 006668 5F 65CM Pigtail Flush Catheter
(j) 006669 5F 90CM 8SH Pigtail Flush Catheter
(k) 006670 5F 65CM 8SH Straight Flush Catheter
(l) 006671 5F 90CM 8SH Straight Flush Catheter
(n) 200050 Flush Catheter 5F 65CM Pigtail
(o) 200051 Flush Catheter 5F 90CM Pigtail
(p) 200052 Flush Catheter 5F 65CM Straight
(q) 200053 Flush Catheter 5F 65CM Straight
(r) 099168 Special Flush Catheter
(s) 099068 4/5F Pediatric Flush Catheter.
Recall #Z-766/783-4.
CODE All lots.
MANUFACTURER Bard Urological Division, Glens Falls, New York.
RECALLED BY USCI Division, C.R. Bard, Inc., Billerica, Massachusetts, by
letter March 10, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 102,765 units were distributed.
REASON The firm failed to file a 510(k) premarket notification for
their percutaneous polyamide flush catheters.
_______________
PRODUCT Intraocular Lens: (a) Model 120UV; (b) Model 121UV,
(c) Model 68SUV; (d) Model P329UV; (e) Model 351UV.
Recall #Z-784/788-4.
CODE Serial numbers: (a) 2D7392, P25955, P25807; (b) 4F4049;
(c) 2L3658, Q32864, 3A2703, P59149; (d) 6R1545;
(e) 313765.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter December 21, 1993. Firm-initiated
recall complete.
DISTRIBUTION California, Germany, Mexico, Australia.
QUANTITY Firm estimates none remains on the market.
REASON Products may be labeled with the incorrect power and model,
which would result in a refractive error if implanted.
_______________
PRODUCT Intraocular Lens, Model 650 CUV. Recall #Z-789-4.
CODE Serial numbers: 4M9101, 4M9105, 4M9106, 4M9108, 4M9109,
4M9110, 9M9113, 4M9703, 4M9709 through 4M9712.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter February 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Florida, New York, Pennsylvania, Minnesota.
QUANTITY 12 lenses
REASON The devices may be labeled with the incorrect dioptic power,
which would result in a refractive error if implanted.
_______________
PRODUCT Dinamap Portable Vital Signs Monitors, used to measure
patient blood pressure and body temperatures:
(a) Model 8100; (b) Model 8110; (c) Model 8120.
Recall #Z-799/801-4.
CODE Serial numbers: (a) L1966, L2002-L2061, L2063-L2249,
L2251-L2255, L2257-L2260, L2262-L2268, L2270-L2276,
L2278-L2281, L2283-L2285, L2287-L2291, L2294, L2296-L2299,
L2301-L2304, L2306-L2308, L2311-L2312, and L2314;
(b) J1747-1815, J1817-J1865;
(c) H1102, H1128-H1130, and H1132-H1177.
MANUFACTURER S.C.I. Manufacturing, Inc., Huntsville, Alabama.
RECALLED BY Critikon, Inc., Tampa, Florida, by letter December 14, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 466 units.
REASON The monitors' bezels and frames were built with the wrong
threaded inserts, which are too small in diameter for the
holes they were to fit into.
_______________
PRODUCT Reddick-Saye Suture Needle Grice Needle Modification
Model RS-GSNM, for suturing under laparoscopic control.
Recall #Z-802-4.
CODE All lot numbers.
MANUFACTURER Ideas for Medicine, Clearwater, Florida.
RECALLED BY Manufacturer, by letter September 3, 1993. Firm-initiated
recall complete.
DISTRIBUTION Colorado, New Jersey, Tennessee, Ohio, Iowa, Florida,
Virginia, Michigan, Washington state, South Carolina,
Minnesota, Arizona, Singapore, Hong Kong, Spain.
QUANTITY 390 units were distributed.
REASON The device fails to function as intended due to lack of
adequate design and quality controls.
_______________
PRODUCT Pediatric Straight Tip Arterial Cannula:
(a) Pediatric Straight Tip Arterial Cannula 1/4" Connector 8
French, Model #75008;
(b) Pediatric Straight Tip Arterial Cannula 1/4" Connector
10 French, Model #75010. Recall #Z-803/804-4.
CODE Lot numbers: (a) 68612002, 68612004, 68707002, 68803001,
68804001, 68808005, 68812007, 68812009, 68903009, 68907003,
68910006, 69003009, 69009008, 69012004, 69101002, 69102004,
69103008, 69105001, 69106001, 69106009; (b) 68701003,
68701004, 68704006, 68706003, 68802001, 68807006, 68810001,
68901001, 68901009, 68903008, 68905002, 68909004, 69007008,
69010003, 69011007, 69101001, 69102004, 69104003, 69105007,
69106001, 69101007.
MANUFACTURER DLP, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by letter December 21. 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 24,000 units were distributed; firm estimates
none remains on the market.
REASON Occlusion at the tip-body interface for the 8 French
Pediatric Straight Tip Arterial Cannula occurs and tip
imperfections exist with the Pediatric Straight Tip Arterial
Cannula 10 French.
_______________
PRODUCT Product pouches. All products in 11" or 12" package for use
in conjunction with cardiopulmonary bypass surgery:
(a) Lancaster Cooling Jackets, Product No. 13500;
(b) Femoral Cannula Kit, Product No. 166041;
(c) Femoral Cannula Placement Kits, Product Nos. 96014,
96017, 96021, 96117, 96121;
(d) Femoral Cannula Insertion Kit, Product No. E1961;
(e) Guidewire Bag, Product No. E1964;
(f) Cardioplegia Management Set, Product No. 13003;
(g) Femoral Cannula Placement Kit, Product No. 96017;
(h) Left Atrial Pressure Monitor Catheter,
Product No. 50005;
(i) Femoral Cannula Placement Kits, Product No. 166042;
(j) DLP Cardio-Kit, Product No. 9901509;
(k) DLP Cardio-Kit, Product No. 9901038;
(l) Dr. Chitwood's Heart Pack, Product No. E1192;
(m) Antegrade/Retrograde Y, Product No. 13050;
(n) Perfusate Delivery Set, Product No. 13055.
Recall #Z-805/818-4.
CODE PRODUCT NO. LOT NO.
13500 6940-1002
166041 6940-1006
96014 6940-1001
96017 6940-1008
6940-2001
6940-2006
96021 6940-1008
6940-2001
96117 6940-1008
6940-2001
96121 6940-1008
E1961 6940-1007
E1964 6940-1001
13003 6940-2004
E1192 6931-1006
E1961 6931-1001
13003 6931-0007
6931-1006
6931-2005
13050 6931-0003
6931-1006
13055 6931-0007
50005 6931-0004
6931-1004
96017 6931-0001
6931-1002
6931-2008
96021 6931-0004
6931-1008
96117 6931-0007
96121 6931-1005
166041 6931-0003
166042 6931-0003
9901038 6931-2001
9901509 6931-1007
All pouch products were assigned a three year expiration
date.
MANUFACTURER DLP, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by letters of March 8, 1994 and April 29,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,527 units were distributed.
REASON The product pouches were not sealed across the entire width
of the pouch, thus causing the products not to be sterile.
_______________
PRODUCT Bird Avian Transport Ventilator, Product #15365, indicated
for short term ventilation of patients during transport.
Recall #Z-830-4.
CODE Serial number sequence KDHC1001 through DHC1299.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
RECALLED BY Manufacturer, by letter January 7, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 133 units were distributed.
REASON The ventilator may unexpectedly switch from volume cycled to
time cycled ventilation when the user pushes the Inspiratory
Time button, and the indicated pressure of the gas and the
volume of gas delivered may be inaccurate.
_______________
PRODUCT Bird "Partner IIi" Respiratory Volume Monitor, Catalog
#15285, indicated for volume measurement and display during
mechanical ventilation of neonates, infants, and pediatrics.
Recall #Z-831-4.
CODE All monitors with serial numbers from KDK0200 through
KDK0239, and all monitors with serial numbers with the
prefix letters KA, KB, or KCK that are equipped with infant
flow/volume sensors.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
RECALLED BY Manufacturer, by letter January 27, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 401 units.
REASON The displayed volume readings exceed the specified accuracy
tolerance due to defective pressure sensor tubing and
calibration.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT USCI Cardiovascular Catheter Sones B HI-Flow 8F 80 cm
(2.67mm), used to record intracardiac pressures to sample
blood, and to introduce substance into the heart and
vessels. Recall #Z-765-4.
CODE Catalog #008719, lot #07HD0049.
MANUFACTURER Bard Urological Division, Glen Falls, New York.
RECALLED BY USCI, Division C.R. Bard, Inc., Billerica, Massachusetts, by
letter March 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Iowa, Michigan, Ohio, Arizona.
QUANTITY 120 pieces were distributed.
REASON Package labeling indicated that the device is a Curve Style
B when in fact it is a Curve Style C.
_______________
PRODUCT KAAT II Plus Intra-Aortic Balloon (IAB) Pump, used to
provide cardiac support to patients whose myocardial oxygen
supply and demand are imbalanced. Recall #Z-797/798-4.
CODE All KAAT II Plus Units and units that have the KAAT II
Plus retrofit. Domestic Cat. No. 0099-0025, Part No.
0099-3000-501; International Catalog No. 0099-0025, Part No.
0099-3000-501; International Catalog No. 0099-0027, Part No.
0099-3000-502;
Retrofit Units -- Domestic: Catalog No. 0099-3406
International: Catalog No. 0099-3407
Domestic, international, finish goods, in-process,
retrofitted Serial numbers:
30101P-30115P 040221T 1120416B
30301P-30315P 0030234T 1120421B
30501P-30515P 0050202T 2040401B
30701P-30710P 0050221T 2090402B
30801P-30810P 0060209T 8110205TR
30901P-30920P 0120209T 9040205T
31201P-31220P (excluding 31209P) 0120210T 9040216T
2111901-2111903P 0120211T 9050206T
1030401B 9050211T
1030402B 9080219T
1100403B 9100203T
1120409B 61121011TR
1120415B.
MANUFACTURER Kontron Instruments, Inc., Everett, Massachusetts.
RECALLED BY Manufacturer, by letter January 21, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 89 units distributed; 25 units retrofitted.
REASON A defect exists in the software code that controls the pump
which prevents the pump from receiving a trigger signal from
the control unit when a patient has an ECG amplitude signal
below 0.75 millivolts and is being monitored using a direct
ECG skin lead cable.
_______________
PRODUCT Medex Pressure Monitoring Kits, used for internal blood
pressure monitoring and sampling:
(a) Catalog #MX9501; (b) Catalog #MX9502;
(c) Catalog #MX9504; (d) Catalog #MX9504-CST;
(e) Catalog #MX9505; (f) Catalog #9505-CST;
(g) Catalog #MX9506; (h) Catalog #SX000513;
(i) Catalog #SX000514; (j) Catalog #SX031653;
(k) Catalog #SX021514. Recall #Z-819/829-4.
CODE Lot numbers: (a) 23I03145; (b) 23I03145;
(c) 23G23132, 23I02239, 23I14050;
(d) 23G23133, 23I03147; (e) 23H27180; (f) 23I25018;
(g) 23G23130, 23H27181; (h) 23H11043; (i) 23H11041;
(j) 23I03198; (k) 23H28010.
MANUFACTURER Medex, Inc., Dublin, Ohio (component).
RECALLED BY Medex, Inc., Hiliard, Ohio, by letter November 4, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, England, Germany, New Zealand, Japan.
QUANTITY 1,250 kits were distributed.
REASON Aspiration of air occurs through the push button flush out
component during blood sampling, and leakage of fluid occurs
out of the push button flush component during activation.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Pitman-Moore Opti-Cor Collagen Corneal Shield for animals.
Recall #V-043-4.
CODE 3168, 3111.
MANUFACTURER Bausch and Lomb Pharmaceuticals, Tampa, Florida.
RECALLED BY Manufacturer, by letter November 30, 1993. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY Firm estimates none remains on the market.
REASON Dissolution failure.
-12-
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