Steris SYSTEM 1E Liquid Sterilant System Recalled for Hose Disconnection
Steris Corporation is recalling 6,051 SYSTEM 1E Liquid Sterilant Processing Systems because the hose can disconnect when the unit is left on, causing water leakage and property damage.
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 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 recall is classified as FDA Class II and involves significant property damage reports due to water leakage, which aligns with the 'Severe' criteria in the rubric.
Plain-English summary
Steris Corporation is recalling 6,051 units of the SYSTEM 1E Liquid Sterilant Processing System. The affected units are Model P6500 with serial numbers ranging from 400000 through 406294. These systems are intended for the liquid chemical sterilization of manually cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices, including endoscopes and their accessories.
The recall was initiated after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends, the hose can disconnect or separate. This disconnection results in water leakage that can cause damage to property.
The affected units were distributed nationwide in the United States, as well as in Bahrain and Hong Kong. Consumers and healthcare facilities should stop using the affected units and contact Steris Corporation for further instructions on the recall.
The recalled product
- Product
- The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and…
- Manufacturer
- Steris Corporation
- Affected units
- 6,051
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 (2)
- Model #: P6500
- S/N 400000 through 406294
Distribution
Distributed nationwide across the United States.
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