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Terminated

Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501

FDA Recall Z-0831-2008 · Posted 2008-01-30

Recalling FirmAM2 PAT INC
Recall StatusTerminated
Product CodeFOZ
Date Initiated2007-12-11
Date Terminated2010-12-02

Reason for Recall

Lack of assurance of sterility by manufacturer

Firm Action

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

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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