Maquet Getinge Mayo Pulmonary Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling Mayo Pulmonary Packs because a design feature may prevent sterilization gas from reaching all parts, 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 risk-of-harm product (sterility failure in a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-T 44201 Mayo Pulmonary Packs (Material: 701064834) used for extracorporeal circulation. The recall affects batch numbers 3000041415, 3000044885, and 3000077738, which were distributed nationwide.
The recall is issued because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas 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 product may not be fully sterile.
Healthcare facilities and users should stop using the affected products and contact Maquet Cardiovascular for further instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
- 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: 3000041415 3000044885 3000077738
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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