Recall Z-1739-2024
Cardinal Health 200, LLC · initiated March 27, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Codes / lots: UDI/DI 50885380113114 (Case), 10885380113116 (Each), Lot Numbers: 231251D5
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 03/27/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the following: Locate, segregate, and cease use of the affected product, disseminate the notice to those who handle the product. Distributors were directed to notify their customers. CONTACT the appropriate Customer Service group to arrange return of product and with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Details
- Recall number
- Z-1739-2024
- Initiated
- March 27, 2024
- Posted by FDA
- May 1, 2024
- Product code
- GBX – Catheter, Irrigation
- Quantity
- 98 cases of 12
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1735-2024 Class II | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… | 03/27/2024Open, Classified |
| Z-1736-2024 Class II | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… | 03/27/2024Open, Classified |
| Z-1737-2024 Class II | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… | 03/27/2024Open, Classified |
| Z-1738-2024 Class II | Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits… | 03/27/2024Open, Classified |