BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
FDA Recall Z-0740-2017 · Posted 2016-12-12
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeOFT
Date Initiated2016-11-07
Date Terminated2017-09-12
Product Quantity4500
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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