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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 regard see related information
Date Initiated by Firm June 03, 2022
Date Posted July 19, 2022
Recall Status1 Terminated 3 on April 14, 2023
Recall Number Z-1407-2022
Recall Event ID 90492
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Code Information (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249. 
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Lacy Stewart
417-647-3205
Manufacturer Reason
for Recall		 Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
FDA Determined
Cause 2		 Process change control
Action The recalling firm initiated the recall via telephone on 6/3/2022 to the direct consignee of Item 830019017, explained the reason for recall, and instructed the product be quarantined. The recalling firm also contacted the end user who had received distribution from the direct consignee. The end user was informed of the error and was requested to remove the affected lot from their inventory. The recalling firm worked with the end user to have the kits returned to the direct consignee where they were placed in quarantine. Regarding the recall of Item #830099008 and Item #830014016, the direct consignees were notified on 6/6/2022 via telephone requesting the affected kits be placed on hold and moved to a quarantined area. A follow-up email was sent to the recall coordinator for the direct consignees (which was the same recall coordinator) on 6/16/2022 which contained a correction notice. The email explained the issue and said the recalling firm has already performed rework on the kits in the inventory at their location (the two direct consignee locations) so no additional actions were required except for the completion of the reply form to indicate receipt of the notice. The attached Medical Device Correction Notice was dated 6/16/2022 and explained the issue, the affected product, the health risk assessment, and the actions taken by the recalling firm, which included rework of the products that had been returned to the direct consignees. The enclosed replay form was to be completed acknowledging the consignee has read and understands the notice.
Quantity in Commerce 86 kits
Distribution Distribution was made to MO. There was no foreign/military/government distribution.
Total Product Life Cycle TPLC 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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