Z-0740-2017Class II

BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists...

Name: Z-0740-2017 BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists...
Creator: Becton Dickinson & Company
Published: 2016-11-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2016-11-07 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure on 2016-11-07. FDA classified it as Class II and gives the reason as "BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069". 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-0740-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2016-12-12
Terminated: 2017-09-12
Recalling firm: Becton Dickinson & Co
Product: BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
Product code: OFT Spinal Epidural Anesthesia Kit
Reason for recall: BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: BD sent an Urgent Product Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately review their inventory for the affected product. Return the affected products with the Business Response Card form following the instruction on the enclosed packing instruction. The completed form should be faxed to 1-866-240-5212 or email the completed form to [email protected]. Customers with questions were instructed to call 1-866-792-5451. For questions regarding this recall call 866-792-5451.
Quantity in commerce: 4500
Distribution: Nationwide Distribution
Product codes and lots: B01K089D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0740-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0740-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

Product code OFT

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)