Hemofiltration Standard Pack including BC 60 Plus-T 8036.… recallZ-0490-2018 · Maquet · initiated May 22, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
55 kits were distributed after their expiration date of September 2015.
FDA root cause category: Incorrect or no expiration date
What the company is doing
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.
Recall details
- Recall number
- Z-0490-2018
- Status
- Terminated
- Initiated by the company
- May 22, 2017
- Posted by the FDA
- Dec 20, 2017
- Recalling firm
- Maquet
- Quantity
- 55 units
- Product code
- DWE
- FDA submissions
- K053025
- Distribution
- Distributed to the states of NM, CA, and IL.
Product description
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.
Code information (models, lots, serial numbers)
Lot/batch number: 3000001571 UDI code: 607567206489
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HF Std Pack with BC 60 Plus T8036Datascope Corp. · Tubing, Pump, Cardiopulmonary Bypass1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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