Agency classClass IIOur severity:High FDA (Devices)·Z-2149-2019·Announced 2019-09-25

Maquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly

Maquet is recalling 54 cardiopulmonary sets because quick connectors were assembled in reverse, preventing proper priming and function.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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. The hazard involves a device that may not function as intended due to assembly errors, which poses a risk of harm to patients during use, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 54 units of the Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0 (Model Number BEQ-HLS-7050 USA, Part Number 701052794). The recall involves Lot 70131093 and UDI 04037691741543. The affected products were distributed to hospitals and facilities in Arkansas, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Tennessee, and Wisconsin.

The recall was initiated because the sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines. This incorrect assembly results in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this error, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.

Healthcare facilities should stop using the affected sets and contact Maquet Cardiovascular US Sales, LLC for instructions on how to return the products or obtain replacements. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product: Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Cardiopulmonary Equipment
Hazard: device-malfunction
improper-assembly
Affected units: 54

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 (2)

Lot 70131093
UDI 04037691741543

Distribution

Distributed in 17 states:

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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