Gyrus Acmi Recalls Disposable Myringotomy Knives Due to Sterility Concerns
Gyrus Acmi is recalling disposable myringotomy knives because they may lack sterility assurance. The affected units were distributed in the US, Canada, and the UK.
What this means for you
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 is classified as FDA Class II, and the hazard involves a lack of sterility assurance for a surgical instrument, which poses a risk of harm even without reported injuries.
Plain-English summary
Gyrus Acmi, Incorporated is recalling 100 boxes of 6 units of disposable myringotomy knives, reference number 130715. The recall is due to a lack of sterility assurance for the devices. These surgical instruments are intended to perforate the tympanic membrane to allow the placement of a bent tube or to provide ventilation or drainage of the middle ear.
The affected products were distributed worldwide, specifically in the United States (nationwide), Canada, and the United Kingdom. The specific code for the recalled lot is JC477666. The devices are marked as sterile and are for prescription use only.
Healthcare providers and consumers should stop using the affected myringotomy knives immediately. Users should contact Gyrus Acmi, Incorporated for further instructions on how to return or dispose of the products.
The recalled product
- Product
- GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent 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)
- JC477666
Distribution
Distributed nationwide across the United States.
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