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Recall Observatory FDA recall evidence

Device product

HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator

Z-1372-2016

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-1372-2016

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: HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786

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.