[Recalled] 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 no
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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 c |
|---|---|
| Brand / manufacturer | Datascope Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2178-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 27 July 2017 |
| EAN / barcode | 0607567204133 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Datascope Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.