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Terminated

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

FDA Recall Z-2002-2016 · Posted None

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDWE
Date Initiated2016-05-09
Date Terminated2017-03-28
Product Quantity17 units

Reason for Recall

Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

US in the state of GA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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