FDA Recall Terminated

BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

Recall: Z-3028-2011 · Initiated April 22, 2011

Recall

Recall Number
Z-3028-2011
Event Number
59218
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
KST
Status
Terminated
Root Cause
Device Design
Initiated
April 22, 2011
Posted
August 16, 2011
Terminated
June 6, 2012
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

Reason

BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.

Action

BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.

Distribution

Nationwide (USA) Distribution.

Quantity

1,744,000