regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
- Company
- Roi Cps Llc
- Recall Initiated
- July 24, 2024
- Posted
- September 17, 2024
- Recall Number
- Z-3159-2024
- Quantity
- 3387 kits
- Firm Location
- Republic, MO
Reason for Recall
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Distribution
US Nationwide distribution in the state of North Carolina.
Lot / Code Info
GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS
Root Cause
Process control
Action Taken
ROi 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.