Maquet Custom Tubing Packs Recalled for Potential Endotoxin Exposure
Maquet Cardiovascular is voluntarily recalling 72,000 custom tubing packs for oxygenators due to a potential risk of endotoxin exposure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (endotoxin) without reported illnesses, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall of Custom Tubing Packs for oxygenators. The recall is being conducted due to a potential risk of exposure to endotoxin for these products.
The recall affects 72,000 units distributed nationwide in the United States. The products are identified by specific serial number prefixes, including T, TOP, BE-TOP, BO-TOP, BO-T, BEQ-T, and BEQ-TOP.
This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not specify specific instructions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Custom Tubing Packs Custom tubing pack for oxygenators
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 72,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- T xxxxx
- TOP xxxxx
- BE-TOP xxxxx
- BO-TOP xxxxx
- BO-T xxxxx
- BEQ-T xxxxx
- and BEQ-TOP xxxxx.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular Us Sales, Llc
See all →- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
FDA (Devices) · 2020-12-23
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2020-11-18
- HighMaquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
- HighMaquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
Same hazard · endotoxin exposure
See all →- HighStryker 1.2mm Cross Cut Fissure Recalled for Endotoxin Levels
FDA (Devices) · 2024-10-23
- HighImactis Navigation Kit Recalled for Potential Microbial Contamination
FDA (Devices) · 2020-01-29
- HighMaquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk
FDA (Devices) · 2016-04-20
- HighMaquet QUADROX-i oxygenators recalled for potential endotoxin exposure
FDA (Devices) · 2016-04-20