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Terminated

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 Recall Z-2325-2012 · Posted 2012-09-06

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeLRT
Date Initiated2012-08-02
Date Terminated2013-09-04
Product Quantity77 packs

Reason for Recall

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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