Device product
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Z-3159-2024
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 95229
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3387 kits
- Official record key
device-enforcement:Z-3159-2024
Official wording
Reason: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
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
Distribution pattern: US Nationwide distribution in the state of North Carolina.
Derived failure modes
-
Unknown
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.