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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm November 07, 2016
Date Posted December 12, 2016
Recall Status1 Terminated 3 on September 12, 2017
Recall Number Z-0740-2017
Recall Event ID 75802
Product Classification Spinal epidural anesthesia kit - Product Code OFT
Product BD Spinal Anesthesia Tray
The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
Code Information B01K089D
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
866-792-5451
Manufacturer 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 2		 Error in labeling
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 bd6549@stericycle.com. Customers with questions were instructed to call 1-866-792-5451. For questions regarding this recall call 866-792-5451.
Quantity in Commerce 4500
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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