Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21

FDA device recall Z-1389-2008 · posted 2008-04-04 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NZW

Quantity affected

1,313,225 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 who

Date initiated

2008-02-28

Date posted

2008-04-04

Date terminated

2020-02-18

Location

Round Lake, IL