Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB Recalled by Datascope Corporation Due to There is a potential for the over-pressure safety...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corporation directly.
Affected Products
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.
Quantity: 8
Why Was This Recalled?
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Where Was This Sold?
This product was distributed to 2 states: FL, IA
About Datascope Corporation
Datascope Corporation has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report