Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of stopcock ports.
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 risk-of-harm product (sterile medical device) where the sterilization process may be compromised, but the source text does not report any illnesses or injuries.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pediatric tubing sets (Material: 709000078). The recall involves specific batch numbers: 3000047631, 3000054421, 3000063290, 3000071804, 3000073166, and 3000075337. 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 reaching the fluid path between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.
Healthcare facilities and users of these pediatric extracorporeal circulation packs should stop using the affected units and contact Maquet Cardiovascular for instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
- Manufacturer
- Maquet Cardiovascular, LLC
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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