—#111958

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 their accessories.

FDA product code: MED — Sterilant, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090036, K101409, K102462
Affected lot / code info: Model #: P6500, S/N 400000 through 406294

Why it was recalled

The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.

Timeline

Recall initiated: 2012-08-01
Posted by FDA: 2012-09-07
Terminated: 2014-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111958. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.