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U.S. Department of Health and Human Services

Class 2 Device Recall Regard

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 Class 2 Device Recall Regardsee related information
Date Initiated by FirmNovember 30, 2021
Create DateJanuary 10, 2022
Recall Status1 Terminated 3 on August 07, 2023
Recall NumberZ-0469-2022
Recall Event ID 89149
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
ProductRegard, T AND A - Rogers, sterilized convenience kits
Code Information 1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023
FEI Number 3014527682
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information ContactLacy Stewart
417-730-3900
Manufacturer Reason
for Recall		Kits lacks rubber latex warning label.
FDA Determined
Cause 2		Error in labeling
ActionA customer notification email dated 11/30/2021 was sent with recall instructions as follows: 1. Check: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the table are in your inventory. 2. Quarantine: If the affected kits are identified, please quarantine the product and do not further distribute. 3. Label Affected kits: Use the label template attached to this notice to label affected kits in your inventory prior to shipping to customers. The label includes the statement "This kit contains a URETHRAL CATHETER RED RUBBER 12FR that contains natural rubber latex which may cause allergic reactions." The label should be placed in a location on the outer wrapper of the kits that is visible to end users. 4. Reply: Please complete the attached reply form indicating any inventory on hand at your facility. If you do not have inventory, please return the form indicating "0" inventory on hand. 5. Notify: Please immediately notify any customers to who, you have distributed or forwarded kits affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 6. End users: Notices sent to end users should include the label template and instruction to label affected kits in their inventory. The label should be placed in a location on the outer wrapper of the kits that is visible to users of the kits.
Quantity in Commerce195 kits
DistributionUS Nationwide distribution in the state of MO.
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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