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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 March 21, 2022
Create Date May 09, 2022
Recall Status1 Terminated 3 on December 28, 2023
Recall Number Z-1051-2022
Recall Event ID 89951
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Regard brand CABG Pack A and B - Spartanburg
Code Information Item Number: 800208017, Lot 91156  UDI: (01)10194717112495(17)230101(10)91156
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 were packed into shipping boxes incorrectly.
FDA Determined
Cause 2		 Under Investigation by firm
Action An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs.com so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
Quantity in Commerce 85 kits
Distribution Recall impacted one domestic consignee in NC
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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