Agency classClass IIOur severity:High FDA (Devices)·Z-1516-2019·Announced 2019-06-05

Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

Maquet Cardiovascular is recalling Pediatric ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

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 the Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack (Material: 701051515). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) distributed nationwide. The affected batch numbers are 3000041127, 3000049458, 3000061103, 3000065550, 3000071378, 3000075338, and 3000081601.

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

Healthcare facilities and distributors should identify and quarantine the affected units. The source text does not specify a specific consumer action for the general public, as these are medical devices intended for professional use.

The recalled product

Product: Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical/Procedural Supplies
Hazard: sterility-failure
infection-risk

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 →

Same manufacturer · Maquet Cardiovascular, LLC

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Same hazard · sterility failure