Steris Recalls AMSCO Evolution Steam Sterilizer Transfer Carriages
Steris Corporation is recalling 936 AMSCO Evolution steam sterilizer transfer carriages because they may unlatch when overloaded or maneuvered with excessive force.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the mechanism of injury (unlatching) is identified, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Steris Corporation is recalling 936 units of the AMSCO Evolution steam sterilizer Transfer Carriage. These mobile, wheeled units are used to transport loading cars into and out of steam sterilizer units. The recall covers serial numbers ranging from 030061103 to 0535531220.
The firm discovered that the transfer carriages may unlatch if they are overloaded or if they are pulled or maneuvered incorrectly or with excessive force. This defect could result in the loss of the load during transport.
The affected units were distributed worldwide, including nationwide in the United States and in specific countries such as Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, the United Arab Emirates, and Venezuela. Users should stop using the affected transfer carriages and contact Steris Corporation for instructions on how to proceed.
The recalled product
- Product
- AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
- Manufacturer
- Steris Corporation
- Affected units
- 936
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number Range: 030061103 - 0535531220
Distribution
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