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U.S. Department of Health and Human Services

Class 2 Device Recall Regard Reusable RT Bronch Kit

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 Class 2 Device Recall Regard Reusable RT Bronch Kitsee related information
Date Initiated by FirmMay 03, 2022
Create DateJune 09, 2022
Recall Status1 Terminated 3 on June 27, 2022
Recall NumberZ-1255-2022
Recall Event ID 90199
Product Classification General surgery tray - Product Code LRO
Productregard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Code Information UDI (01)10194717102335(17)230531(10)90135, Lot Number 90135, Exp. 2023-05-31
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact
417-730-3900
Manufacturer Reason
for Recall		Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
FDA Determined
Cause 2		Other
ActionROI notified the sole consignee with a MEDICAL DEVICE RECALL NOTICE by email on 05/03/2022. The letter explained the problem and requested the following actions: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the item/lot number listed in the above table are in your inventory. 2. HOLD: Quarantine all affected kits in your inventory and do not further distribute or use. 3. REPLY: Complete the recall reply form attached to this notice and return to lacy.stewart@roiscsc.com. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. 4. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this recall notice. You may include a copy of this notice as well as the notice issued by Medline to supplement your communication.
Quantity in Commerce24 kits
DistributionFL
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.
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