Agency classClass IIOur severity:High FDA (Devices)·Z-1766-2022·Announced 2022-09-28

HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment

Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.

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: This is an FDA Class II recall for a sterility breach on a critical medical device used for cardiac and respiratory support. No illnesses or injuries have been reported, but the sterility compromise on life-supporting equipment constitutes a risk-of-harm scenario that warrants a High severity classification.

Plain-English summary

Maquet Medical Systems USA is recalling the BEQ-HLS 5050 USA (HLS Set Advanced 5.0), a preconnected set used for extracorporeal respiratory and cardiovascular support as part of the CARDIOHELP System. The recall affects approximately 6,871 units in the United States and 18,670 units worldwide, distributed to Canada and Australia.

The recall was expanded due to a potential breach in the sterility barrier that may compromise the product's sterility. An initial recall began on November 6, 2020. The affected lot numbers are 3000192081, 3000193363, 3000196200, 3000208697, and 3000216172.

Equipment users should check whether their device lot number is among those affected.

The recalled product

Product: BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Manufacturer: Maquet Medical Systems USA
Category: Medical Device — Cardiac and Respiratory Support Equipment
Hazard: sterility-breach
infection-risk

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 (5)

UDI-DI: 04058863076355 Lots 3000192081
3000193363
3000196200
3000208697
3000216172

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Maquet Medical Systems USA 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 →

Same manufacturer · Maquet Medical Systems USA

See all →

High
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Moderate
Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
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Same hazard · sterility breach