Z-0183-2018Class II

BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes...

Name: Z-0183-2018 BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes...
Creator: Becton Dickinson & Company
Published: 2017-05-25
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-05-25 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of... on 2017-05-25. FDA classified it as Class II and gives the reason as "Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G...". 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-0183-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-11-28
Terminated: 2018-06-27
Recalling firm: Becton Dickinson & Co
Product: BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
Product code: FMF Syringe, Piston
Reason for recall: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle mL 12.7mm 30G.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: BD sent recall notification letters to all direct consignees (wholesaler, hospital, and retail) on May 25, 2017. BD is requesting wholesalers (distributors) to notify any accounts or additional locations that may have received the recalled product from them. BD gives the option to distributors to provide their customer list to BD if they would like BD to notify their customers. BD is requesting retail pharmacies to notify consumers that may have received the recalled product from them. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590. A 2nd notification was sent to consignees in a letter dated Aug 30, 2017 that includes all 3 lots that are in scope of the recall. Most of the direct consignees identified in the first recall action were also identified as affected for the second (expanded) recall action since they received either two or all three recall lots. All affected consignees that received any of the three lots have been combined into one consignee list. These customers will be notified of the expanded recall communication (second recall letter dated Aug 30, 2017). To minimize customer disruption, BD will conduct effectiveness check on the second recall letter only, since it covers the recall action for all three affected lots and combines all affected consignees from both actions (first and second/expanded recall). This will allow us to verify that the affected consignees received the notification and took the necessary actions for all three recall lots without having to contact them multiple times for two different letters that cover the same recall action. Details of the effectiveness are as follows: 1.Letters will be mailed with UPS tracking. The effectiveness check level will be established by the FDA classification letter. 2.A Business Response Card is included with the letter to assist direct consignees in responding to the field action. 3.BD will attempt to contact by phone/email (as applicable) non-respondents
Quantity in commerce: 7,839,340 units
Distribution: Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
Product codes and lots: Lot Numbers: 6291768, 6312558 & 6340590. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2018-02-08

Product code FMF

K024112Class IIBd Insulin SyringeBecton, Dickinson & CO / cleared 2003-01-09

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)