RecallDepth

VACUTAINER Brand Push Button Blood Collection Sets.

This recall has been terminated (originally issued February 25, 2004).

Company
Becton Dickinson & Company
Recall Initiated
December 17, 2003
Posted
February 25, 2004
Terminated
March 15, 2004
Recall Number
Z-0549-04
Quantity
4400
Firm Location
Franklin Lakes, NJ
Official Source
View on FDA website ↗

Reason for Recall

A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.

Distribution

The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA.

Lot / Code Info

Batch # 3218665

Root Cause

Other

Action Taken

BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.

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