Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness
Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.
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: This is an FDA Class II recall of a medical device where temperature exposure during storage may have compromised product effectiveness. Although no illnesses or injuries have been reported, the potential for patient harm from improperly disinfected medical equipment constitutes a high-risk situation.
Plain-English summary
Nanosonics Ltd Sonex-HL ultrasound probe disinfectant (80 mL bottles, Model N00037) is being recalled. The product is used with the Trophon EPR disinfection system for cleaning and disinfecting ultrasound probes.
The recall was issued because the product was exposed to elevated temperatures from June through August 2021 prior to delivery. This temperature exposure may have compromised the product's disinfection effectiveness.
All lots received between June 1, 2021 and September 30, 2021 are affected. Healthcare facilities and others using this product should verify the receipt date of their supplies.
If you have received affected product, contact Mckesson Medical-Surgical Inc. for return or replacement options. Do not use product from the affected date range if you cannot verify proper storage conditions.
The recalled product
- Product
- NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- effectiveness-loss
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 (3)
- GTIN: 09350855000061
- 09350855000078
- 09350855000023
Distribution
Distributed nationwide across the United States.
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