Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom 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 (medical device) where sterility cannot be assured, posing a risk of infection, but no injuries or illnesses have been reported yet, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID custom tubing sets used for extracorporeal circulation. The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. During the sterilization process, this 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) for the stopcock ports cannot be assured, meaning the devices may not be sterile.
The affected products are identified by the following batch numbers: 3000047632, 3000052206, 3000055637, 3000060482, and 3000067466. The material code for these items is 701055862. The recall is classified as Class II by the FDA, indicating that 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 distributors should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on returns or replacements. No specific illnesses or injuries have been reported in the source text, but the risk of infection due to non-sterile equipment is a significant concern for patients undergoing extracorporeal circulation.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
- 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: 3000047632 3000052206 3000055637 3000060482 3000067466
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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