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STERIS SYSTEM 1E Liquid Chemical Sterilant Processing… recallZ-0869-2012 · Steris Corporation Hopkins Facility · initiated Dec 7, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation Hopkins Facility or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which

FDA root cause category: Software design

What the company is doing

The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.

Recall details

Recall number
Z-0869-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 7, 2011
Posted by the FDA
Jan 25, 2012
Recalling firm
Steris Corporation Hopkins Facility
Quantity
3,882 units were distributed
Product code
MED
FDA submissions
K090036, K102462
Distribution
Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.

Product description

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

Code information (models, lots, serial numbers)

MED. Serial Numbers: 400000 through 405499 are subject to correction.

Other devices under the same FDA submission

4 devices cleared under K090036, K102462 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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