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.
This recall has been terminated (originally issued December 20, 2017).
- Company
- Maquet
- Recall Initiated
- May 22, 2017
- Posted
- December 20, 2017
- Terminated
- July 12, 2018
- Recall Number
- Z-0490-2018
- Quantity
- 55 units
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
55 kits were distributed after their expiration date of September 2015.
Distribution
Distributed to the states of NM, CA, and IL.
Lot / Code Info
Lot/batch number: 3000001571 UDI code: 607567206489
Root Cause
Incorrect or no expiration date
Action Taken
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.