Z-0564-2013Class II

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA...

Name: Z-0564-2013 Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA...
Creator: Becton Dickinson & Company
Published: 2012-10-02
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-10-02 / Terminated

FDA source

Becton Dickinson & Company began a recall of Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse... on 2012-10-02. FDA classified it as Class II and gives the reason as "BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0564-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-02
Posted: 2012-12-19
Terminated: 2016-05-03
Recalling firm: Becton Dickinson & Co
Product: Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
Product code: FMF Syringe, Piston
Reason for recall: BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
FDA root cause: Mixed-up of materials/components
Action: Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
Quantity in commerce: 2,786,000 units
Distribution: (USA) nationwide
Product codes and lots: Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0564-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code FMF

K980987Class IIBecton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-06-11

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)