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

FDA device recall Z-0740-2017 · posted 2016-12-12 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

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.

Action taken

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 bd6549@stericycle.com. Customers with questions were instructed to call 1-866-792-5451. For questions regarding this recall call 866-792-5451.

Root cause

Error in labeling

Status

Terminated

Product code

OFT

Quantity affected

4500

Distribution

Nationwide Distribution

Date initiated

2016-11-07

Date posted

2016-12-12

Date terminated

2017-09-12

Location

Franklin Lakes, NJ