Sheehy ear ventilation tubes recalled for possible infection risk
Medtronic Xomed is recalling Sheehy ventilation tubes (ear tubes, REF 1013301) because they were not subjected to the required sterilization process. After implantation, this could cause infection and inflammation, potentially leading to temporary hearing impairment, ear fluid discharge, or the need for antibiotics. The notice reports no injuries.
From the FDA notice · Read the official notice ↗
What to do
- Set aside and do not implant lots 0231048279 and 0231048280 (UDI-DI 20763000281636).
- Check product packaging for REF 1013301 and the lot numbers above.
- The notice doesn't say how to get a refund or replacement; contact Medtronic Xomed.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280 (GTIN 20763000281636).
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 4000
- Illnesses reported
- None reported
- Manufactured in
- 6743 Southpoint Dr N, Jacksonville, Florida, United States
- Classification
- Class II
- Recall number
- Z-0387-2027
In the FDA's words
- Description
- Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280 (GTIN 20763000281636). Ventilation tubes, that provide a passageway for movement of air between the auditory canal and the middle ear, were not subjected to the required sterilization process, which after implantation could cause infection and subsequent inflammation potentially leading to temporary hearing impairment, otorrhea (fluid discharge) and the need for antibiotics. UDI-DI: 20763000281636. Lots: 0231048279, 0231048280 Distribution: Worldwide - US Nationwide distribution including in the states of NY, AL, VA, MI, AZ, WA, TX, MA, IL, ME, NM, CA, IN, NC, OH, MO, MN, NH, IA, NV, GA, PA, FL, TN, WV, SC, OK, NE, OR, SD, AK, LA, CO, WI, MD, KS, UT, ID, WY, NJ and the countries of Canada, Australia, New Zealand, Hong Kong. Affected quantity: 4000
- Hazard
- Ventilation tubes, that provide a passageway for movement of air between the auditory canal and the middle ear, were not subjected to the required sterilization process, which after implantation could cause infection and subsequent inflammation potentially leading to temporary hearing impairment, otorrhea (fluid discharge) and the need for antibiotics.
2 products in this recall
Medtronic Xomed ear ventilation tubes recalled for sterilization failure
Medtronic Xomed recalled two ear ventilation tube products, the Sheehy Ventilation Tube 5PK Button 1.27 FLPL and the Bobbin Ventilation Tube 5PK 1.14 FLPL, because the tubes were not subjected to the required sterilization process. After implantation, this could cause infection and inflammation, potentially leading to temporary hearing impairment, ear fluid discharge, and the need for antibiotics. The notice reports no injuries.
The agency lists each product separately. Check every one you might have.
- Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280 (GTIN 20763000281636). (this page)Z-0387-2027 · 4000
- BOBBIN VENTILATION TUBE 5PK 1.14 FLPL, REF: 1010201, Lot# 0231048277 (GTIN 20763000281612).Z-0388-2027 · 2000