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U.S. Department of Health and Human Services

Class 2 Device Recall CV Minor Kit

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 Class 2 Device Recall CV Minor Kitsee related information
Date Initiated by FirmMay 20, 2022
Date PostedJune 28, 2022
Recall Status1 Terminated 3 on May 02, 2023
Recall NumberZ-1295-2022
Recall Event ID 90302
Product Classification Cardiovascular procedure kit - Product Code OEZ
Productregard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Code Information Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
Recalling Firm/
Manufacturer
ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information ContactLacy Stewart
417-647-3205
Manufacturer Reason
for Recall
A nonsterile component was packaged in a sterile convenience kit.
FDA Determined
Cause 2
Process change control
ActionThe recalling firm called the consignee on 5/20/2022 to discuss the recall, including quarantine of affected product, customer fulfilment/available inventory, end user facility notification, recall timelines, and establishing a plan for relabeling by the recalling firm personnel at the distribution center. The recalling firm issued an email to the consignee on 5/20/2022 with an attached recall notice that was previously discussed with the consignee. The email requested the consignee to quarantine the kits and immediately notify the end user facilities who have been shipped the affected kits. In the email, the recalling firm reported they would be sending someone to the direct account and to the end user facilities to complete the correction of the affected kits. The attached letter dated 5/20/22 informed the customer of the reason for recall, health risk assessment, and the actions to be taken by customers. The letter contained a picture of the non-sterile Ultrasound Gel that is to be discarded from the kits. A Recall Reply Form was enclosed to indicate the quantity of product in the customer's possession. The customer was also supposed to indicate that they have read and understand the notice and it has been forwarded to all customers who have been shipped the affected product.
Quantity in Commerce180 kits
DistributionUS Nationwide distribution in the state of FL.
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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