—#151303

Product

BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure

FDA product code: OFT — Spinal Epidural Anesthesia Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: B01K089D

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-11-07
Posted by FDA: 2016-12-12
Terminated: 2017-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.