| Class 2 Device Recall BD Vacutainer |  |
Date Initiated by Firm | November 20, 2007 |
Date Posted | January 23, 2008 |
Recall Status1 |
Terminated 3 on September 08, 2008 |
Recall Number | Z-0589-2008 |
Recall Event ID |
45965 |
510(K)Number | K011984 |
Product Classification |
Blood Specimen Collection Device - Product Code JKA
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Product | BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ |
Code Information |
Lot #'s : 7117874, 7157882, 7159943, 7180478, 7215299, 7215300, 7324340, and 7234341. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact | 201-847-7186 |
Manufacturer Reason for Recall | Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174 |
Quantity in Commerce | 105,200 USA; 400 Canada |
Distribution | Worldwide-USA and Canada |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JKA
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