Device 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 Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
Z-2002-2016
Product summary
- Event
- Event 74341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-2002-2016
Official wording
Reason: Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Code information: Lot/batch No: 3000003260, Part number 701050175
Distribution pattern: US in the state of GA
Derived failure modes
-
Unknown
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.