Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium
FDA device recall Z-0831-2008 · posted 2008-01-30 · Terminated
Recall details
- Recalling firm
- AM2 PAT INC
- Reason for recall
- Lack of assurance of sterility by manufacturer
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FOZ
- Distribution
- Nationwide
- Date initiated
- 2007-12-11
- Date posted
- 2008-01-30
- Date terminated
- 2010-12-02
- Location
- Angier, NC
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