FDA Recall Terminated

BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection

Recall: Z-0816-2011 · Initiated October 5, 2010

Recall

Recall Number
Z-0816-2011
Event Number
56972
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FMI
Status
Terminated
Root Cause
Process control
Initiated
October 5, 2010
Posted
December 27, 2010
Terminated
June 6, 2012
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection

Reason

There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.

Action

BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.

Distribution

Nationwide Distribution

Quantity

4,223,200