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Terminated

VACUTAINER Brand Push Button Blood Collection Sets.

FDA Recall Z-0549-04 · Posted 2004-02-25

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2003-12-17
Date Terminated2004-03-15
Product Quantity4400

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011984BD VACUTAINER PUSH BUTTON BLOOD COLECTION SETBecton, Dickinson & CO · 2001-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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