Maquet Pediatric Extracorporeal Circulation Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific pediatric tubing sets for extracorporeal circulation 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 infection (risk-of-harm product) without reported injuries or illnesses in the source text, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric tubing sets. These products are used for extracorporeal circulation (ECC). The recall is due to a potential issue with the sterilization process.
During sterilization, the closed stopcock and non-vented cap 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) of the stopcock ports cannot be assured, meaning the sterility of the device is not guaranteed.
The affected products are identified by Batch Numbers 3000079888 and 3000081748. The distribution pattern is listed as nationwide. Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected units if found.
The recalled product
- Product
- Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
- 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: 3000079888 3000081748
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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