Z-0549-04

VACUTAINER Brand Push Button Blood Collection Sets

Name: Z-0549-04 VACUTAINER Brand Push Button Blood Collection Sets
Creator: Becton Dickinson & Company
Published: 2003-12-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2003-12-17 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of VACUTAINER Brand Push Button Blood Collection Sets on 2003-12-17. The reason FDA records is "A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0549-04
Status: Terminated
Initiated: 2003-12-17
Posted: 2004-02-25
Terminated: 2004-03-15
Recalling firm: Becton Dickinson & Co
Product: VACUTAINER Brand Push Button Blood Collection Sets.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: packaging
FDA root cause: Other
Action: BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.
Quantity in commerce: 4400
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.
Product codes and lots: Batch # 3218665

Product code JKA

K011984Class IIBd Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO / cleared 2001-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)