Z-2192-2011

BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For...

Name: Z-2192-2011 BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For...
Creator: Becton Dickinson & Company
Published: 2011-03-01
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-03-01 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the... on 2011-03-01. The reason FDA records is "Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2192-2011
Status: Terminated
Initiated: 2011-03-01
Posted: 2011-05-13
Terminated: 2012-11-30
Recalling firm: Becton Dickinson & Co
Product: BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the pharmacy setting.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.
Root cause tag: packaging
FDA root cause: Packaging
Action: BD sent an Urgent: Product Recall letter with return response forms to direct consignees on 03/01/11 and 03/02/11 via UPS. The letter identified the affected product and lot along with the reason for the recall. The letter asked customers to complete the enclosed Distributor Packing List and to follow the instructions provided on the Packing List for returning the affected product. The firm will issue a credit upon receipt of the affected product. Customers can contact BD Customer Service if they need assistance or have questions regarding the recall.
Quantity in commerce: 161,000 units
Distribution: Worldwide Distribution -- USA, including the states of NJ, IL, LA, NM, OH, NV, and VA, and country of Canada.
Product codes and lots: Ref# 305213, Lot# 0007829

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)