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U.S. Department of Health and Human Services

Class 2 Device Recall SafetyGlide

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 Class 2 Device Recall SafetyGlidesee related information
Date Initiated by FirmJuly 24, 2006
Date PostedSeptember 28, 2006
Recall Status1 Terminated 3 on December 03, 2007
Recall NumberZ-1525-06
Recall Event ID 36026
510(K)NumberK992734 
Product Classification syringe - Product Code MEG
ProductBD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950.
Code Information Reorder Number: 305945 Lot: 5312395 and 5312394.  Reorder Number: 305950 Lot: 5319508 and 5300175.
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactGreg Morgan
201-847-4344
Manufacturer Reason
for Recall		BD received reports of needle assembly disengagement from the syringe.
FDA Determined
Cause 2		Other
ActionRecall letters were sent to all wholesalers and end users on 7/28/2006.
Quantity in Commerce1,294,200 units
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.
510(K) Database510(K)s with Product Code = MEG
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