—#111874

Product

100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

FDA product code: LRT — Indicator, Sterilization
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K092745
Affected lot / code info: Product code KCT; Lot number: 60263

Why it was recalled

On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Steris sent a Urgent Voluntary Recall Notice letter dated August 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Steris has learned that the VIS-U-All tubing is not performing to product specifications. Upon receipt of replacement product we ask that you destroy any remaining inventory of the affected lot in your possession. In the interim period, should you receive a failing result following a sterilization cycle, the results must be handled in accordance with your internal hospital procedures. We apologize for any inconvenience this matter may cause you. For further questions please call 1-(800) 548-4873.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.

Timeline

Recall initiated: 2012-08-02
Posted by FDA: 2012-09-06
Terminated: 2013-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.