[Recalled] Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing S |
|---|---|
| Brand / manufacturer | Datascope Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2002-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 09 May 2016 |
| EAN / barcode | 3000003260 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
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.