FDA Medical Device Recalls (openFDA)
AM2 PAT INC: Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
- Recall number
- Z-0832-2008
- Recalling firm
- AM2 PAT INC
- Product
- Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
- Status
- Terminated
- Initiated
- 2007-12-11
- Posted
- 2008-01-30
- Terminated
- 2010-12-02
- Reason
- Lack of assurance of sterility by manufacturer
- Root cause
- Process design
- 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.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- ALL LOTS
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3001574774
- Firm city
- Angier
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28