Z-2178-2018 Class II Terminated
FDA device recall Z-2178-2018 was initiated by Datascope Corporation on July 27, 2017 and is designated Class II. Reason for recall: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. The recall status is terminated (terminated February 7, 2020). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- July 27, 2017
- Termination Date
- February 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Reason for Recall
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Distribution Pattern
The products were distributed to the following US states: IA and FL.
Code Information
UDI 0607567204133