FDAMay 9, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
What to do
FDA enforcement status: Terminated
Brands named
datascope
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABattery Charging Station; Model: 0998-00-0802;2026-02-06
- FDACS100 IABP. Software Version CS100 IABP Q.01.2026-01-23
- FDACS300 IABP. Software Version CS300 IABP C.01.2026-01-23
- FDACardiosave Rescue. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid. Intra-Aortic Balloon Pump system.2025-11-04
- FDACardiosave Hybrid2025-10-23
- FDACardiosave Rescue2025-10-23
- FDAMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-012024-09-17
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