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U.S. Department of Health and Human Services

Class 1 Device Recall Sierra PerFilled

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 Class 1 Recall
Sierra PerFilled
see related information
Date Posted January 30, 2008
Recall Status1 Open
Recall Number Z-0833-2008
Recall Event ID 46182
Premarket Notification
510(K) Number
K032417 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 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
Code Information ALL LOTS
Recalling Firm/
Manufacturer
AM2 PAT INC
455 W Depot Street
Angier, North Carolina 27501
For Additional Information Contact Dushyant Patel
919-552-9689
Manufacturer Reason
for Recall
Lack of assurance of sterility by manufacturer
FDA Determined
Cause 2
DESIGN: 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.
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = AM2 PAT INC.
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