Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect
Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.
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 is classified as FDA Class II, and the hazard involves a risk of harm (inadequate sterilization) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Steris Corporation is recalling 2,889 units of the AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems. These devices are intended for the terminal sterilization of medical devices in healthcare facilities using VAPROX HC Sterilant.
The recall is due to a potential defect where a punctured cup of sterilant may expire while the system is powered down. Upon power-up, the unit may fail to detect the expired sterilant, allowing subsequent sterilization cycles to be run with expired material. This could result in inadequate sterilization of medical devices.
The affected units were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities should stop using the affected systems and contact Steris Corporation for instructions on how to proceed.
The recalled product
- Product
- AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned…
- Manufacturer
- Steris Corporation
- Affected units
- 2,889
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 (6)
- UDI numbers 00724995151973
- 00724995151980
- 00724995151997
- and 00724995152000
- 00724995154677
- 00724995154684
Distribution
Distributed nationwide across the United States.
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