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U.S. Department of Health and Human Services

Class 1 Device Recall B. Braun

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 Class 1 Device Recall B. Braunsee related information
Date Initiated by FirmDecember 11, 2007
Date PostedJanuary 30, 2008
Recall Status1 Terminated 3 on December 02, 2010
Recall NumberZ-0836-2008
Recall Event ID 46182
Product Classification Saline IV Flush Pre Filled Syringe - Product Code FOZ
ProductB. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
Code Information ALL LOTS
Recalling Firm/
Manufacturer
AM2 PAT INC
455 W Depot Street
Angier NC 27501
For Additional Information ContactDushyant Patel
919-552-9689
Manufacturer Reason
for Recall
Lack of assurance of sterility by manufacturer
FDA Determined
Cause 2
Process design
ActionAM2PAT 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.
DistributionNationwide
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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