Recall Z-2002-2016 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Datascope Corporation
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 Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of b
| Date | May 9, 2016 |
| Status | Terminated |
| Reason | Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits. |
| Root cause | Under Investigation by firm |
| Action | Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer. |
| Quantity | 17 units |
| Distribution | US in the state of GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.