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U.S. Department of Health and Human Services

Class 2 Device Recall Vacutainer

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  Class 2 Device Recall Vacutainer see related information
Date Initiated by Firm August 11, 2006
Date Posted October 12, 2006
Recall Status1 Terminated 3 on May 08, 2007
Recall Number Z-0034-2007
Recall Event ID 36275
510(K)Number K011984  
Product Classification Blood Collection Set - Product Code JAK
Product BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile
REF 368656
23G x 3/4'' x 12'' 0.6 x 19mm x 305mm
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REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm
Code Information Catalog number 367352 Lot # 6100596 Catalog number 367352 Lot # 6100597 Catalog number 367352 Lot # 6152413 Catalog number 368656 Lot # 6090251 Catalog number 368656 Lot # 6094813 Catalog number 368656 Lot # 6094840 Catalog number 368656 Lot # 6111757 Catalog number 368656 Lot # 6121663 Catalog number 368656 Lot # 6146186
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Michael Malis
201-847-4717
Manufacturer Reason
for Recall		 A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.
FDA Determined
Cause 2		 Other
Action Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers.
Quantity in Commerce 110,300 units
Distribution Nationwide.
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 = JAK and Original Applicant = BECTON DICKINSON & CO.
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