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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Gastro Bypass

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 Class 2 Device Recall Regard Gastro Bypasssee related information
Date Initiated by FirmMay 03, 2022
Create DateJune 08, 2022
Recall Status1 Terminated 3 on May 31, 2024
Recall NumberZ-1250-2022
Recall Event ID 90135
510(K)NumberK952204 
Product Classification laparoscopy kit - Product Code FDE
ProductRegard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Code Information Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024)
FEI Number 3014527682
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
Manufacturer Reason
for Recall		Potential for the tip of the electrode to detach during use.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them.
Quantity in Commerce125 units
DistributionDistributed to North Carolina.
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 = FDE
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