B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
Recall
- Recall Number
- Z-0829-2008
- Event Number
- 46182
- Firm
- AM2 PAT INC
- FEI Number
- 3001574774
- Product Code
- FOZ
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- December 11, 2007
- Posted
- January 30, 2008
- Terminated
- December 2, 2010
- Address
- 455 W Depot Street, Angier, NC, 27501
Description
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
Lack of assurance of sterility by manufacturer
AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes.
Nationwide