100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide steriliz
FDA device recall Z-2325-2012 · posted 2012-09-06 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LRT
- Quantity affected
- 77 packs
- Distribution
- 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.
- Date initiated
- 2012-08-02
- Date posted
- 2012-09-06
- Date terminated
- 2013-09-04
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU (K092745) | STERIS Corporation | 2010-11-19 |