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Recall Observatory FDA recall evidence

Device product

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

Z-0740-2017

November 07, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 75802
Status
Terminated
Classification
Class II
Quantity
4500
Official record key
device-enforcement:Z-0740-2017

Official wording

Reason: 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.

Code information: B01K089D

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled