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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm November 17, 2005
Date Posted February 04, 2006
Recall Status1 Terminated 3 on March 03, 2008
Recall Number Z-0468-06
Recall Event ID 34199
510(K)Number K850505  
Product Classification Connector, Catheter - Product Code GCD
Product BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. The product is molded and assembled by Avail, Northeast. It is then supplied to BD (Juncos, PR) where it is allocated to be packaged and sold in kits, trays, Perisafe and bulk.
Code Information Reorder Number 400273 Lot Number 5164796
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Greg Morgan
201-847-4344
Manufacturer Reason
for Recall		 The catheter connector could not be sufficiently tightened to secure the catheter tubing.
FDA Determined
Cause 2		 Other
Action Recall letters were sent to all direct consignees and potential end users of the product on 11/17/2005. Letters were mailed via UPS second day air.
Quantity in Commerce 1410 units
Distribution The devices were distributed to wholesalers and hospitals nationwide. There are no international or govt accounts.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GCD and Original Applicant = PARKE-DAVIS CO.
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