Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 44701 Pediatric ECC Custom Tubing Sets (Material: 701064825). The recall involves batch number 3000071198 and 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. 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 consumers who have these specific tubing sets should stop using them and contact Maquet Cardiovascular for further instructions or a replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
- 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: 3000071198
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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