Edwards Lifesciences Recalls Suction Wands Due to Plastic Particulate
Edwards Lifesciences is recalling specific models of rigid suction wands because plastic particulate was found inside the sterile pouch and within the wand.
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 medical device with a contamination hazard (plastic particulate) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Edwards Lifesciences, LLC is recalling certain lots of Rigid Suction Wands, specifically models S099 and S099B. The recall was initiated after the manufacturer discovered plastic particulate inside the sterile packaging and within the internal diameter of the wand.
The affected products are intended for use in removing excess fluid from the surgical field. Suction wands are designed for handheld use, while pericardial sumps are intended for stationary use. The recall covers 171,587 units of model S099 and 505,107 units of model S099B.
These products were distributed worldwide, including nationwide in the United States and in Canada. Healthcare facilities and users should stop using the affected lots and contact Edwards Lifesciences for further instructions on the recall.
The recalled product
- Product
- Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
- Manufacturer
- Edwards Lifesciences, 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)
- Models S099 and S099B
Distribution
Distributed nationwide across the United States.
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