Z-0745-2017Class II

BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended...

Name: Z-0745-2017 BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended...
Creator: Becton Dickinson & Company
Published: 2016-08-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-08-08 / Open, Classified / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from... on 2016-08-08. FDA classified it as Class II and gives the reason as "BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0745-2017
Classification: Class II
Status: Open, Classified
Initiated: 2016-08-08
Posted: 2016-12-12
Recalling firm: Becton Dickinson & Co
Product: BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to [email protected] (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to [email protected]. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.
Quantity in commerce: 1,788,150 units
Distribution: Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.
Product codes and lots: 5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0745-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0745-2017	Class II	Ongoing	Voluntary: Firm initiated	2016-12-21	2016-12-12

Product code JKA

K030573Class IIBd Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions / cleared 2003-05-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)