AM2 PAT INC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
AM2 PAT INC
Lot Codes / Batch Numbers
ALL LOTS
Products Sold
ALL LOTS
AM2 PAT INC is recalling Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL due to Lack of assurance of sterility by manufacturer. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility by manufacturer
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026