Maquet Pediatric Cardiac Surgery Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Pediatric Cardiac Surgery Packs because a design flaw may prevent proper sterilization of the 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 potential failure to assure sterility in a medical device used for cardiac surgery, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack (Material: 709000006). The recall affects batch number 3000059175, which was 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) of the stopcock ports cannot be assured.
Healthcare facilities should stop using the affected products and contact Maquet Cardiovascular for further instructions.
The recalled product
- Product
- Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
- 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: 3000059175
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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