Z-1937-2016Class II

Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general...

Name: Z-1937-2016 Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general...
Creator: Becton Dickinson & Company
Published: 2016-03-25
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-03-25 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection on 2016-03-25. FDA classified it as Class II and gives the reason as "BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1937-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-06-09
Terminated: 2017-04-03
Recalling firm: Becton Dickinson & Co
Product: Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Product code: FMF Syringe, Piston
Reason for recall: BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.
Quantity in commerce: 811,200 units
Distribution: Nationwide Distribution to NY only
Product codes and lots: Catalog (REF #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1937-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1936-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09
Z-1937-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-09

Product code FMF

K110771Class IIBd Single Use, Hypodermic SyringeBecton, Dickinson and Company / cleared 2011-05-13

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)