Maquet Getinge Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because the stopcock design 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 medical device where sterility cannot be assured, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack (Material: 701065190). The recall involves Custom Tubing Sets for Extracorporeal Circulation (ECC) with batch numbers 3000069382 and 3000074502. The distribution was 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 components being used in medical procedures.
Healthcare facilities and distributors should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. Patients who have already used these products should consult their healthcare provider if they have concerns regarding sterility or potential infection.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
- 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: 3000069382 3000074502
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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