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 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 medical device where sterility cannot be assured, posing a risk of harm (infection) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 28903 Adult ECC Packs (Material: 709000093). The recall involves specific batch numbers: 3000045728, 3000051160, and 3000058050. The products were distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration on the custom tubing sets for extracorporeal circulation may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities and users should stop using the affected products and contact Maquet Cardiovascular for further instructions or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
- Manufacturer
- Maquet Cardiovascular, LLC
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 (1)
- Batch Numbers: 3000045728 3000051160 3000058050
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.
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