Erbe USA Inc: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Erbe USA Inc
- Product
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Reason / hazard
- A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
- Recall initiated
- 2026-06-26
- Code info
- UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3
- Product quantity
- 1126 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Marietta
- State
- GA
- Country
- United States
- Event id
- 99341
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