Z-0490-2018 Class II Terminated
FDA device recall Z-0490-2018 was initiated by Maquet on May 22, 2017 and is designated Class II. Reason for recall: 55 kits were distributed after their expiration date of September 2015. The recall status is terminated (terminated July 12, 2018). Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- May 22, 2017
- Termination Date
- July 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
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.
Reason for Recall
55 kits were distributed after their expiration date of September 2015.
Distribution Pattern
Distributed to the states of NM, CA, and IL.
Code Information
Lot/batch number: 3000001571 UDI code: 607567206489