regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

FDA device recall Z-3159-2024 · posted 2024-09-17 · Open, Classified

Recall details

Recalling firm

ROi CPS LLC

Reason for recall

Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.

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.

Root cause

Process control

Status

Open, Classified

Product code

OEQ

Quantity affected

3387 kits

Distribution

US Nationwide distribution in the state of North Carolina.

Date initiated

2024-07-24

Date posted

2024-09-17

Location

Republic, MO