CanadaErbe Flexible Cryoprobe devices (model/catalogue numbers 20402-401, 20402-411 and 20402-410) are affected; affected units are identified by lot or serial numbers consisting of more than 10 numbers — contact the manufacturer to confirm if your device is in an affected lot. The probes have ruptured or burst during activation, causing or potentially causing serious injuries. Users should stop using products from affected lots, follow Erbe’s field safety notice instructions, and contact the manufacturer for more information.
What's being recalled
Companies: Erbe Elektromedizin Gmbh, Waldhoernlestrasse 17, Tuebingen, Germany, 72072.
How to identify it
Affected products: Erbe Flexible Cryoprobe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 20402-401
Affected products: Erbe Flexible Cryoprobe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 20402-411
Affected products: Erbe Flexible Cryoprobe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 20402-410
The hazard
Erbe Elektromedizin Gmbh has been made aware of cases of Erbe Flexible Cryoprobes rupturing/bursting during activation. Serious injuries have occurred or could occur due to the failure mode associated with this removal action. Users should stop to use products out of affected lots and follow Erbe's instructions as provided in the field safety notice.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)