FDA Enforcement
Class II
Ongoing
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Recall: Z-1736-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1736-2024
- Event ID
- 94309
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2024
- Initiation Date
- March 27, 2024
- Classification Date
- May 1, 2024
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States
Description
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Reason
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Code Info
UDI/DI 50192253016428 (Case), 20192253016427 (Box), 10192253016420 (Each), Lot Numbers: 231251D2, 231252D2, 231253D2, 231254D2, 231255D2, 231256D2, 231151D2, 231152D2, 231153D2, 210751D2, 210752D2, 210753D2, 210754D2, 210755D2
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
Quantity
2905 cases of 12