Agency classClass IIOur severity:Severe FDA (Devices)·Z-1573-2019·Announced 2019-06-05

Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for non-sterile use in a critical surgical procedure (ECC) represents a significant risk of serious harm, aligning with the 'Severe' criteria for structural/functional defects in medical devices.

Plain-English summary

Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 36504 ADULT ECC PACKs (Material: 701065765) due to a potential sterility assurance issue. The recall affects specific batch numbers: 3000043680, 3000046039, 3000049205, 3000052613, 3000055536, and 3000062791. The 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 between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which could lead to the use of non-sterile equipment during extracorporeal circulation procedures.

Healthcare facilities and users should stop using the affected products immediately and contact Maquet Cardiovascular for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical / Sterile 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