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Terminated

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

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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