Maquet Getinge-BO-TOP 20700 Small Patient Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design flaw 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 (potential sterility failure leading to infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 20700 Small Patient 3/8 tubing sets (Material 701050966) used for extracorporeal circulation. The recall involves specific batch numbers: 3000063810, 3000068490, 3000071784, and 3000076463. The products were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, posing a potential risk of infection if the devices are not sterile.
Healthcare facilities and users of these specific tubing sets should stop using the affected batches immediately and contact Maquet Cardiovascular for further instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966
- 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: 3000063810 3000068490 3000071784 3000076463
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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