Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.
What this means for you
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 is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalizations or serious injuries are reported in the source text, but the risk involves a medical device where sterility cannot be assured.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-T 41301 BUMC ECC PACK custom tubing sets used for extracorporeal circulation. The recall is due to a potential defect in the sterilization process. Specifically, 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. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected products are identified by the following batch numbers: 3000049454, 3000054311, 3000054314, and 3000055640. The material code for these items is 701065209. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and users of these products should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on how to proceed. The distribution pattern for these products was nationwide.
The recalled product
- Product
- Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
- 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: 3000049454 3000054311 3000054314 3000055640
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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