Gyrus Acmi Recalls Contaminated Silicone Tympanostomy Tubes
Gyrus Acmi is recalling one lot of tympanostomy tubes because the silicone was contaminated with ethylene vinyl acetate copolymer.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a material contamination without reported harm.
Plain-English summary
Gyrus Acmi, Incorporated is recalling one lot of PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044. The product is a sterile, prescription-only tympanostomy tube manufactured with ethylene oxide sterilization.
The recall was initiated because the silicone used in the manufacturing process was found to be contaminated with ethylene vinyl acetate copolymer. The affected lot code is JC470075, and the distribution quantity is 10 boxes containing 60 units.
The product was distributed worldwide, specifically to the state of Kansas in the USA and the country of Korea. Healthcare providers and patients should stop using the affected tympanostomy tubes and contact Gyrus Acmi for further instructions.
The recalled product
- Product
- PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
- Manufacturer
- Gyrus Acmi, Incorporated
- Hazard
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)
- JC470075
Distribution
Distributed in 1 state:
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