Recall Z-0740-2017
Becton Dickinson & Company · initiated November 7, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
Codes / lots: B01K089D
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.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-0740-2017
- Initiated
- November 7, 2016
- Posted by FDA
- December 12, 2016
- Terminated
- September 12, 2017
- Product code
- OFT – Spinal Epidural Anesthesia Kit
- Quantity
- 4500
- Distribution
- Nationwide Distribution
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ