Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection
Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating 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: This is a Class II FDA recall involving a risk-of-harm medical device where improper configuration could prevent adequate disinfection and potentially lead to patient infection. No illnesses or injuries have been reported, making this a serious but theoretical risk scenario.
Plain-English summary
Steris Corporation is recalling 129 Hookup devices (Model 2-8-540HAN). These devices provide the interface between Advantage Plus Automated Endoscope Reprocessors and endoscopes, allowing disinfectant delivery to clean endoscope channels.
The Instructions for Use (IFU) and the online reference system (Hookup Lookup/HULU) contained incorrect information about proper hookup connections and parameter settings.
Using incorrect hookup connections or parameter sets may prevent endoscopes from being properly disinfected, which may result in patient contamination or infection.
The affected units were distributed worldwide, including to the United States and 30+ countries. Healthcare facilities should contact Steris Corporation for corrected instructions and verify proper hookup configuration before continuing use.
The recalled product
- Product
- Hookup Model/Catalog Number: 2-8-540HAN 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
- 129
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 (20)
- Lot Code: UDI-DI 00677964086885
- Lot Numbers 415308
- 415665
- 422921
- 456865
- 458947
- 461749
- 463591
- 465821
- 467121
- 467705
- 468813
- 480858
- 484468
- 513285
- 517588
- 533998
- 544724
- 585095
- 617851
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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