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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Blistered Omnifix L.L. Syringe

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 Class 2 Recall
B. Braun Blistered Omnifix L.L. Syringe
see related information
Date Posted September 24, 2009
Recall Status1 Terminated on October 07, 2009
Recall Number Z-2249-2009
Recall Event ID 53080
Premarket Notification
510(K) Numbers
K052117  K071459 
Product Classification Syringe, Piston - Product Code FMF
Product B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump.
Code Information Lot Number: 7B2775
Recalling Firm/
Manufacturer
I-Flow Corporation
20202 Windrow Dr
Lake Forest, California 92630-8152
Manufacturer Reason
for Recall
I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately. They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt. The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.
Quantity in Commerce 569 units
Distribution France
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 = FMF and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FMF and Original Applicant = I-FLOW CORP.
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