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Recall Observatory FDA recall evidence

Device product

Custom Tubing Packs Custom tubing pack for oxygenators

Z-1374-2016

February 23, 2016

Class II

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
Event
Event 73390
Status
Terminated
Classification
Class II
Quantity
72,000 units in total
Official record key
device-enforcement:Z-1374-2016

Official wording

Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.

Code information: containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx, and BEQ-TOP xxxxx.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.