Maquet Getinge-BO-TOP 26300 Custom Tubing Sets Recalled for Sterility Assurance Issues
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, 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 risk-of-harm product (medical device) where the sterility assurance level cannot be verified, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 26300 CUSTOM PACK tubing sets (Material: 701050975) used for extracorporeal circulation. The recall involves specific batch numbers: 3000043848, 3000050583, 3000050645, 3000053626, and 3000054146. 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of non-sterile medical devices being used in patient care.
Healthcare facilities and users should identify any affected units by checking the batch numbers listed above. Users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions regarding the recall.
The recalled product
- Product
- Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
- 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: 3000043848 3000050583 3000050645 3000053626 3000054146
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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