Recall Z-1195-2013 ยท OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Cardinal Health, Medical Products & Services
Presource PBDS, General Laparoscopy, Kit, Circulator
| Date | May 3, 2013 (initiated Mar 26, 2013) |
| Status | Terminated |
| Reason | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. |
| Root cause | Packaging process control |
| Action | Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this |
| Quantity | 4,571 Kits total |
| Distribution | Distributed in the states of AR, MS, SC, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.