Recall Z-0490-2018 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Maquet
Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
| Date | Dec 20, 2017 (initiated May 22, 2017) |
| Status | Terminated |
| Reason | 55 kits were distributed after their expiration date of September 2015. |
| Root cause | Incorrect or no expiration date |
| Action | Medical Device Recall (Removal) Notices were sent to customers via FedEx on 5/22/2017. The letters identified the affected device and the issue. Users are asked to examine their inventory to determine if any of the affected product is on hand. If found, affected devices should be removed and quarantined. Customers should contact Maquet/Getinge Customer Support at 1-888-627-8383 to obtain instructions on returning the affected devices. The Medical Device Recall Removal Response Form provided should be completed and returned. Questions should be directed to your Maquet/Getinge representati |
| Quantity | 55 units |
| Distribution | Distributed to the states of NM, CA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053025 | JOSTRA HLM TUBING SET Maquet Cardiopulmonary, AG, Nov 10, 2005 |