Recall Z-2180-2018— Datascope Corporation
Class II · Terminated
Class II FDA medical device recall by Datascope Corporation, initiated 2017-07-27, terminated 2020-02-07. It names one FDA 510(k) clearance: K080592. Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 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: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through..
- Recalling firm
- Datascope Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-27
- Terminated
- 2020-02-07
- Firm location
- Fairfield, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.