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U.S. Department of Health and Human Services

Class 1 Device Recall DeRoyal Pacemaker Tray Pgybk

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 Class 1 Device Recall DeRoyal Pacemaker Tray Pgybksee related information
Date Initiated by FirmMay 14, 2021
Date PostedJune 10, 2021
Recall Status1 Terminated 3 on April 21, 2023
Recall NumberZ-1832-2021
Recall Event ID 87949
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductDeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Code Information Lot Number 54239375, exp. 02/01/2022
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 Commerce12 trays
DistributionUS Nationwide distribution to the states of MS, VA, LA, and NY.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LRO
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