Advanced Sterilization Products Recalls STERRAD 200 System Carriage Units
Advanced Sterilization Products is recalling STERRAD 200 System Carriages because they may become dislodged under excessive load.
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 device can become dislodged, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage, part number 10208. This device is used as a tool to expedite the loading and unloading of processed items from a STERRAD 200 sterilizer.
The recall is being issued because the carriage can potentially become dislodged when an excessive load is applied. The recall covers 2,457 units that were distributed nationwide in the United States and in various countries including Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and the United Kingdom.
Users of the STERRAD 200 System Carriage should stop using the device and contact Advanced Sterilization Products for further instructions on how to proceed with the recall.
The recalled product
- Product
- STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 2,457
Distribution
Distributed nationwide across the United States.
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