Agency classClass IIOur severity:High FDA (Devices)·Z-1653-2019·Announced 2019-06-05

Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.

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 involves a risk-of-harm product (sterility failure in a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge Custom Tubing Sets for Extracorporeal Circulation (ECC). The affected products are the BEQ-TOP 15801 1/2 inch ECC Pack (Material 701055490R01, Batch 3000050886) and the BEQ-TOP 15801 1/4 in ECC Pack (Material 701055490R02, Batches 3000066508 and 3000081906). These products were distributed nationwide.

The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.

Healthcare facilities and users should stop using the affected tubing sets immediately and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical / Cardiovascular
Hazard: sterility-failure
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 (2)

Batch Numbers: (1) 3000050886 (2) 3000066508
3000081906

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 183 recalled by Maquet Cardiovascular, 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 183 products in this recall →

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Same hazard · sterility failure