Maquet Getinge-BO-TOP 30901 Custom CPB Pack Recall for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Custom CPB Packs because a design feature may prevent proper sterilization, 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 injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK (Material: 701055372). The recall affects batch number 3000061506, which was distributed nationwide.
The recall is due to a potential issue with the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities should stop using the affected units and contact Maquet Cardiovascular for further instructions.
The recalled product
- Product
- Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
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: 3000061506
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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