FDA
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.
55 kits were distributed after their expiration date of September 2015.
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 representative or call the Maquet/Getinge Customer Support at 1-888-627-8383.