Recall Z-0977-2023 ยท GBX Catheter, Irrigation
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
| Date | Jan 18, 2023 (initiated Dec 14, 2022) |
| Status | Open, Classified |
| Reason | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips. |
| Root cause | Unknown/Undetermined by firm |
| Action | Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown above. 2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to |
| Quantity | 3550 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.