CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Hemofiltration Standard Pack including BC 60 Plus-T recalled by Maquet
Maquet is recalling Hemofiltration Standard Pack including BC 60 Plus-T 8036, distributed in California, Illinois, New Mexico. The recall was initiated on 22 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0490-2018
- FDA event ID
- 78765
- Recalling firm
- Maquet, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 30 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 May 2017 | Recall initiated by company | |
| 30 Jan 2018 | Classified by FDA | +253 days |
| 7 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
55 kits were distributed after their expiration date of September 2015.
Product as listed by the 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.
Where it was distributed
Distributed to the states of NM, CA, and IL.
Questions about this recall
Why was it recalled?
55 kits were distributed after their expiration date of September 2015.
Which lots are affected?
Lot/batch number: 3000001571 UDI code: 607567206489
Where was it sold?
Distributed to the states of NM, CA, and IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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