Steris Endoscope Reprocessor Hookups: Incorrect Instructions Risk Improper Disinfection
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
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: FDA Class II medical device with documented risk of patient harm. The source describes a risk-of-harm product where documentation errors could lead to improper disinfection and result in patient contamination or infection. This fits the rubric category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Steris Corporation has recalled Hookup Model 2-8-540CAS units (Lot codes: 438165, 472172, 559354, 587523), which are components of Advantage Plus Automated Endoscope Reprocessors used to deliver disinfectant to endoscope channels. The product has been distributed worldwide throughout the United States and to numerous countries.
The recall is due to incorrect instructions for use (IFU) in the product documentation and online reference system called Hookup Lookup (HULU). Because of these documentation errors, users may select an incorrect hookup connection or apply incorrect parameters when using the equipment.
Use of incorrect hookup connections or parameters may prevent endoscopes from being properly disinfected, which poses a risk of patient contamination or infection.
The recalled product
- Product
- Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids…
- Manufacturer
- Steris Corporation
- Affected units
- 6
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 (5)
- Lot Code: UDI-DI 00677964086878
- Lot Numbers 438165
- 472172
- 559354
- 587523
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Steris Corporation under a single FDA (Devices) 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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