FDA Device

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

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 You Should Do

Remedy

Maquet sent via express mail and hand delivered a recall letter and response form dated May 9, 2016 to their sole customer.

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Products

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 th
Brand
Datascope Corporation
UPC
Lot/batch No: 3000003260, Part number 701050175

Units Affected

17 units

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