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U.S. Department of Health and Human Services

Class 2 Device Recall HEP LOCK

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 Class 2 Device Recall HEP LOCKsee related information
Date Initiated by FirmFebruary 28, 2008
Date PostedApril 04, 2008
Recall Status1 Terminated 3 on February 18, 2020
Recall NumberZ-1384-2008
Recall Event ID 46912
Product Classification Heparin Lock Flush Solution, USP - Product Code NZW
ProductBaxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information All Lots
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactMs. Jacqueline Kunzler
224-270-5158
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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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 Commerce335,860 vials
DistributionWorldwide 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 CycleTPLC Device Report
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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