FDA Enforcement
Class II
Ongoing
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Recall: Z-3159-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3159-2024
- Event ID
- 95229
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ROi CPS LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- July 24, 2024
- Classification Date
- September 17, 2024
- Address
- 3000 E Sawyer Rd, Republic, MO, 65738-2758, United States
Description
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
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
Distribution
US Nationwide distribution in the state of North Carolina.
Quantity
3387 kits