Z-0816-2011

BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x...

Name: Z-0816-2011 BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x...
Creator: Becton Dickinson & Company
Published: 2010-10-05
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-10-05 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ... on 2010-10-05. The reason FDA records is "There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub". 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-0816-2011
Status: Terminated
Initiated: 2010-10-05
Posted: 2010-12-27
Terminated: 2012-06-06
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046. If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.
Quantity in commerce: 4,223,200
Distribution: Nationwide Distribution
Product codes and lots: Catalog Number 367342; Lot numbers: 0145457, 0152300, 0153981, 0153982, 0158081, 0158082, 0158084, 0160664, 0160666, all exp 5/31/2012; Lot numbers 0165202, 0165205, 0165207, 0165218, 0165226, 0165227, 0165232, 0165234, 0176872, 0179208, 0179209, 0179212, 0180023, 0180026, 0180027, 0180028, 0180040, 0180042, all exp 6/30/2012; Lot numbers 0196209, 0196210, 0201399, 0201400, 0201402, 0208593, 0211641, all exp 7/31/2012.

Product code FMI

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)