Z-3159-2024 Class II Ongoing
FDA device recall Z-3159-2024 was initiated by ROi CPS LLC on July 24, 2024 and is designated Class II. Reason for recall: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. The recall status is ongoing. Affected quantity: 3387 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- July 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3387 kits
Product Description
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason for Recall
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Distribution Pattern
US Nationwide distribution in the state of North Carolina.
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