Steris Corporation is recalling 1,254 Hookup devices used to connect endoscopes to automated reprocessors (AER). These units were shipped with incorrect Instructions for Use (IFU) and listed with incorrect parameters on the Hookup Lookup (HULU) online system. These errors can lead to using the wrong connection or disinfection settings, which may prevent an endoscope from being properly sterilized between patients. Affected models include 2-8-540, 2-8-540HAN, 2-8-540CAS, and DSD-110-HU0163, distributed nationwide and internationally.
If an endoscope is not properly disinfected due to incorrect hookup connections or settings, it can remain contaminated with biological material or pathogens. This presents a significant risk of transmitting infections or cross-contamination from one patient to another during subsequent medical procedures.
Correction of instruction materials and online systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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