Medtronic Clearview Blower Mister Model 22120 recalled for potential unsealed sterile packing
Medtronic is recalling 500 units of Clearview Blower/Mister Model 22120 due to potential for unsealed sterile packing that could compromise device 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: Sterile barrier failure on a critical medical device presents inherent risk of contamination and infection. FDA Class II classification with theoretical hazard and no reported illnesses or injuries meets the High severity threshold per the rubric.
Plain-English summary
Medtronic Perfusion Systems is recalling the Clearview Blower/Mister, Model Number 22120, a medical device used in perfusion systems during cardiac surgery. Affected units may have unsealed sterile packing, which could compromise the sterile barrier protecting the device from contamination.
The recall affects 500 units distributed worldwide. Affected lot numbers are 2023040203 and 2023040473 (GTIN 20643169888672). Healthcare facilities using these devices should immediately cease use of affected units and contact Medtronic Perfusion Systems for return and replacement instructions.
The recalled product
- Product
- Medtronic Clearview Blower/Mister, Model Number 22120
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Affected units
- 500
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 (3)
- GTIN 20643169888672
- Lot Numbers: 2023040203
- 2023040473
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Medtronic Perfusion Systems 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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