FDA Enforcement
Class II
Ongoing
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
Recall: Z-1738-2024
·
Reported May 8, 2024
Enforcement
- Recall Number
- Z-1738-2024
- 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 Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
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 50192253016459 (Case), 10192253016451 (Each), Lot Numbers: 210751D6
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
Quantity
64 cases of 6