Z-0590-2008

BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 "...

Name: Z-0590-2008 BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 "...
Creator: Becton Dickinson & Company
Published: 2007-11-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-11-20 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics... on 2007-11-20. The reason FDA records is "Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0590-2008
Status: Terminated
Initiated: 2007-11-20
Posted: 2008-01-23
Terminated: 2008-09-08
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174
Quantity in commerce: 769,200 USA; 1,300 Canada
Distribution: Worldwide-USA and Canada
Product codes and lots: Lot #'s: 6090251R, 6094839, 6111757R, 6121669, 6121676, 6138669, 6146186R, 6152710, 6151443, 6160625, 6164839, 6171015, 6174156, 6178381, 7018205, 7025868, 7026017, 7033728, 7093399, 7093400, 7093403, 7106969, 7106970, 7106971, 7106972, 7113647, 7113648, 7124156, 7124157, 7131786, 7141678, 7141679, 7141680, 7150272, 7162775, 7167155, 7169403, 7172215, 7177261, and 7208536.

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)