Erbe ERBECRYO 2 cryosurgical units recalled for rupture risk
Erbe USA is recalling certain ERBECRYO 2 cryosurgical units because a strong pull on the high-pressure transfer hose can cause CO2 to leak into the return path. The resulting excess pressure may rupture the cryoprobe. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether the unit is model 10402-000 with a serial number up to 11608268 and software version 1.0.3.
- Avoid strong pulls on the high-pressure transfer hose.
- Contact Erbe USA Inc for guidance, since the notice does not specify a remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1126 units
- Illnesses reported
- None reported
- Manufactured in
- 2225 Northwest Pkwy SE, Marietta, GA, United States
- Classification
- Class II
- Recall number
- Z-2938-2026
In the FDA's words
- Description
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 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. UDI-DI 04050147013797/ Serial Numbers: All serial numbers up to 11608268 Software Version: 1.0.3 Distribution: 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. Affected quantity: 1126 units
- 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.