Z-1109-2021Class II

BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

Name: Z-1109-2021 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Creator: Becton Dickinson & Company
Published: 2020-12-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-12-23 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 on 2020-12-23. FDA classified it as Class II and gives the reason as "The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe". 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-1109-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-23
Posted: 2021-02-12
Terminated: 2022-11-21
Recalling firm: Becton Dickinson & Co
Product: BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Product code: FMF Syringe, Piston
Reason for recall: The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.
Quantity in commerce: 155,200 needles
Distribution: Distribution US nationwide and Canada
Product codes and lots: Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1109-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-12

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)