Fort Defiance P2131 Steam Sterilizer Recalled for Plumbing Deposits
Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.
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. The hazard involves a risk of harm (interference with sterilization monitoring components) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Fort Defiance Industries, LLC is recalling 199 units of the P2131 Automated Field Steam Sterilizer. The device is a transportable sterilizer designed for use in austere environments to sterilize porous and non-porous, heat- and moisture-stable materials such as surgical instruments and textiles. The affected units have serial numbers ranging from AFS-0001 through AFS-0199.
The recall is due to a defect identified during long-term storage, such as in military depots. The interaction of stagnant water and dissimilar metals in the device's plumbing produces deposits in the water system. These deposits can potentially interfere with the rear sight gauge and/or the water liquid level switch.
The affected units were distributed nationwide in the states of Pennsylvania, Virginia, and Texas. The source text does not specify the exact end-users or provide specific instructions for consumers on how to stop using the device or obtain a remedy.
The recalled product
- Product
- FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials…
- Manufacturer
- Fort Defiance Industries, LLC
- Affected units
- 199
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 Numbers: AFS-0001 through AFS-0199
Distribution
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