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Class 2 Device Recall HEP LOCK |
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Date Initiated by Firm |
February 28, 2008 |
Date Posted |
April 04, 2008 |
Recall Status1 |
Terminated 3 on February 18, 2020 |
Recall Number |
Z-1388-2008 |
Recall Event ID |
46912 |
Product Classification |
Heparin Lock Flush Solution, USP - Product Code NZW
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Product |
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
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Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact |
Ms. Jacqueline Kunzler 224-270-5158
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Manufacturer Reason for Recall |
Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals |
Quantity in Commerce |
426,675 vials |
Distribution |
Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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