Washer disinfectors recalled because a wire may shift causing internal arcing
Steris is recalling 22 AMSCO 7053HP Washer/Disinfectors because a wire connected to the electrical box may shift out of position, which may result in electrical arcing inside the unit.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."
Plain-English summary
The AMSCO 7053HP Washer/Disinfector from Steris Corporation is being recalled. The device is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments.
A wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. The firm states that the electrical arcing remains internal within the unit, with no risk of shock to users.
The record lists 22 units, carrying UDIs 00724995176662, 00724995176679 and 00724995176655, with serial numbers of distributed units listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Arizona, Colorado, Florida, Georgia, Illinois and Kentucky among other states. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Steris's instructions.
The recalled product
- Product
- Deep-brand Premium Select Surti Papdi Whole Net Wt. 12 oz. (340g) KEEP FROZEN
- Manufacturer
- CHETAK NEW YORK LLC
- Affected units
- 3,509,532
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 (3)
- Lot: 24363
- 25011
- 25046
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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