Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk
Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cryoprobe rupture) that poses a significant risk of injury to patients or providers.
Plain-English summary
Erbe USA Inc is recalling 11,226 units of the ERBECRYO 2 Cryosurgical Unit, Model/Catalog Number 10402-000. The recall covers units with UDI-DI 04050147013797 and serial numbers up to 11608268, running software version 1.0.3. These devices were distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico.
The recall is due to a safety hazard where a strong pull on the high-pressure transfer hose may lead to a pneumatic short circuit between the gas inlet and the connector. This can result in CO2 leaking into the return path, causing excessive pressure that leads to the cryoprobe rupturing.
Healthcare facilities and users of these devices should stop using the affected units immediately. Users should contact Erbe USA Inc for further instructions on how to proceed with the recall.
The recalled product
- Product
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Manufacturer
- Erbe USA Inc
- Hazard
- Affected units
- 1,126
Distribution
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