Medtronic Xomed ventilation tubes recalled for lack of sterilization
Medtronic Xomed is recalling one lot of 5-pack bobbin ventilation tubes (REF 1010201) because they were not sent through the required sterilization process. After implantation, the tubes 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 any unused tubes from lot 0231048277 and do not implant them.
- Check the 5-pack packaging for UDI 20763000281612 and lot 0231048277.
- If a patient received a tube from this lot, contact their care team.
- Contact Medtronic Xomed about the affected lot. The notice doesn't say how to get a return or replacement; ask Medtronic Xomed directly.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- BOBBIN VENTILATION TUBE 5PK 1.14 FLPL, REF: 1010201, Lot# 0231048277 (GTIN 20763000281612).
- Sold in
- Nationwide
- Made for
- Children (under 18 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 2000
- Illnesses reported
- None reported
- Manufactured in
- 6743 Southpoint Dr N, Jacksonville, Florida, United States
- Classification
- Class II
- Recall number
- Z-0388-2027
In the FDA's words
- Description
- BOBBIN VENTILATION TUBE 5PK 1.14 FLPL, REF: 1010201, Lot# 0231048277 (GTIN 20763000281612). 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: 20763000281612. Lots: 0231048277 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: 2000
- 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).Z-0387-2027 · 4000
- BOBBIN VENTILATION TUBE 5PK 1.14 FLPL, REF: 1010201, Lot# 0231048277 (GTIN 20763000281612). (this page)Z-0388-2027 · 2000