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U.S. Department of Health and Human Services

Class 2 Device Recall ReliOn

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 Class 2 Recall
ReliOn
see related information
Date Posted September 20, 2007
Recall Status1 Terminated on June 03, 2008
Recall Number Z-1226-2007
Recall Event ID 38399
Premarket Notification
510(K) Number
K024112 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.
Code Information Catalog number 326743, Batch number 6297350
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes, New Jersey 07417-1815
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Wafa Al-Rimawi
201-847-6795
Manufacturer Reason
for Recall
Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.
Quantity in Commerce 644,500 units
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 = FMI and Original Applicant = BECTON DICKINSON & CO.
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