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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 regardsee related information
Date Initiated by FirmMarch 22, 2023
Date PostedApril 25, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1434-2023
Recall Event ID 91984
Product Classification Cardiac catheterization kit - Product Code OES
ProductSterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Code Information Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383.
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
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionThe recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.
Quantity in Commerce322 kits
DistributionUS Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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