Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles
Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.
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 involves a Class II medical device with a contamination issue (plastic particles) but no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sorin Group USA, Inc. is recalling 18,927 packs of Edwards Lifesciences Suction Wand Model S099B. These products were packaged in Sorin Group Heart/Lung Perfusion Packs and distributed nationwide.
The recall was initiated due to the presence of plastic particles inside the pouch. The source text does not specify which lots are affected or provide details on reported injuries or illnesses.
Consumers and healthcare facilities should check their inventory for this specific model and packaging. The source text does not provide specific instructions for disposal or replacement, but users should contact the recalling firm for further guidance.
The recalled product
- Product
- Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 18,927
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)
- Model S099B
Distribution
Distributed nationwide across the United States.
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