Maquet Getinge-BO-T 6600 Tubing Pack Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific tubing packs used 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 involves a medical device where sterility cannot be assured, posing a risk of infection (risk-of-harm product) without reported injuries or illnesses in the source text, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BO-T 6600 Tubing Pack (Material: 701052324). The recall affects batch number 3000073972, which was 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 during sterilization. This design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.
Healthcare facilities and users of these custom tubing sets for extracorporeal circulation should stop using the affected units and contact Maquet Cardiovascular for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
- 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: 3000073972
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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