Date Initiated by Firm |
May 14, 2021 |
Date Posted |
June 10, 2021 |
Recall Status1 |
Terminated 3 on April 21, 2023 |
Recall Number |
Z-1833-2021 |
Recall Event ID |
87949 |
Product Classification |
General surgery tray - Product Code LRO
|
Product |
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 |
Code Information |
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022 |
Recalling Firm/ Manufacturer |
DeRoyal Industries Inc 200 Debusk Ln Powell TN 37849-4703
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For Additional Information Contact |
865-938-7828
|
Manufacturer Reason for Recall |
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm initiated the recall by email on May 14, 2021. The notice explained the problem and hazard,. Customers were instructed to complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. and return to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com Customers were asked to PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. Distributors were instructed to notify their customers. |
Quantity in Commerce |
66 packs |
Distribution |
US Nationwide distribution to the states of MS, VA, LA, and NY. |
Total Product Life Cycle |
TPLC Device Report
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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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