Date Initiated by Firm |
November 30, 2021 |
Create Date |
January 10, 2022 |
Recall Status1 |
Terminated 3 on August 07, 2023 |
Recall Number |
Z-0469-2022 |
Recall Event ID |
89149 |
Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
Product |
Regard, 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 |
Recalling Firm/ Manufacturer |
ROi CPS LLC 3000 E Sawyer Rd Republic MO 65738-2758
|
For Additional Information Contact |
Lacy Stewart 417-730-3900
|
Manufacturer Reason for Recall |
Kits lacks rubber latex warning label.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
A 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 Commerce |
195 kits |
Distribution |
US Nationwide distribution in the state of MO. |
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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