Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall regard

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall regardsee related information
Date Initiated by FirmDecember 18, 2023
Date PostedJanuary 12, 2024
Recall Status1 Terminated 3 on October 03, 2024
Recall NumberZ-0620-2024
Recall Event ID 93653
Product Classification General surgery tray - Product Code LRO
Productregard Operative LAP, Item Number 800943001; surgical convenience kit
Code Information UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845
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		Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
FDA Determined
Cause 2		Process control
ActionROi CPS issued an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to its sole consignee on 12/18/2023 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: 1. Check inventory for affected product 2. segregate and quarantine affected product 3. Using the attached template, print warning labels (WARNING - Cardinal Health Item 6146LL 16FR SIL Drain Bag Foley Tray HAS BEEN RECALLED Remove and Discard upon Opening Kit) and affix to product. 4. Respond using reply form and return to lacy.stewart@roiscs.com 5. Notify any customers to whom you distributed the product ROi CPS issued an "URGENT EXPANDED MEDICAL DEVICE CORRECTION NOTICE" to its sole consignee on 01/02/2024 via email. The notice was issued after receiving an expansion of the Urgent kit/Tray Component Recall from their supplier, Cardinal Health. Two additional lots have been added. The actions to be taken are the same as the original notice issued on 12/18/2023. If you have any questions relating to this correction notice, please do not hesitate to contact Manager of Quality and Regulatory Affairs at 417-647-3205.
Quantity in Commerce345 units
DistributionUS distribution to Louisiana
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.
-
-