FDA Device recall Z-1602-2022
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
- FDA Device
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037 by Mckesson Medical Surgical Corporate Office, citing facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1602-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-25 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
Reason
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Identifiers
| code_info | GTIN: 09350855000061; 09350855000078; 09350855000023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2022%22
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