Surge Medical Sales Recalls Retrograde Cardioplegia Cannula Due to Stylet Error
Surge Medical Sales is recalling 35 units of the Retrograde Cardioplegia Cannula because they were built with a rigid stylet instead of a flexible one.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The source text does not report any injuries, illnesses, or fatalities, and the defect is a manufacturing error regarding the stylet type.
Plain-English summary
Surge Medical Sales, LLC (DBA Surge Cardiovascular) is recalling 35 units of the Retrograde Cardioplegia Cannula, Model Number RMG-0015S. The device is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The recall was initiated because the devices were built with a rigid insertion stylet instead of the required flexible stylet. The affected units are identified by Lot code 00794-030718.
The affected products were distributed in the United States to the state of South Carolina. Surge Medical Sales is the recalling firm.
The recalled product
- Product
- Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
- Category
- Medical Device — Cardiac Surgery
- Affected units
- 35
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)
- Lot code: 00794-030718
Distribution
Distributed in 1 state:
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