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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 FirmJuly 24, 2024
Date PostedSeptember 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3159-2024
Recall Event ID 95229
Product Classification Angiography/angioplasty kit - Product Code OEQ
Productregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Code Information GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS
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		Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
FDA Determined
Cause 2		Process control
ActionROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 07/24/2024 via Fed Ex. The notice explained the issue, potential risk, and requested the following actions be taken: 1. CHECK: Please review your inventory to determine if the item number and lots listed in the above table is in your inventory. 2. QUARANTINE: If the affected kits are identified, please immediately quarantine the kits and do not further use or distribute them. 3. REPLY: Please complete and return the attached reply form to indicate the quantity of each lot of affected ROi CPS, LLC kits are in your inventory. a. Please email the completed reply form to lacy.stewart@roiscs.com b. Once received, ROi will issue labels to add to each affected kit in your inventory. c. Labels are to be placed in a location that is visible to the end users of the kits. d. Once labeled, the kits can be released back into inventory. 4. NOTIFY: Please notify any customers to whom you have distributed or forwarded the product affected by this urgent medical device correction. 5. END USERS: End users should immediately quarantine affected ROI CPS, LLC kits in their inventory that do not have the above label applied to the kit. Additional labels for customer inventory will be supplied upon request. Please email lacy.stewart@roiscs.com to request additional labels.
Quantity in Commerce3387 kits
DistributionUS Nationwide distribution in the state of North Carolina.
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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