Recall Z-1739-2024 ยท GBX Catheter, Irrigation
Cardinal Health 200, LLC
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
| Date | May 1, 2024 (initiated Mar 27, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 800-444-11 |
| Quantity | 98 cases of 12 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.