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U.S. Department of Health and Human Services

Class 3 Device Recall VisUAll

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 Class 3 Recall
VisUAll
see related information
Date Posted September 06, 2012
Recall Status1 Terminated on September 04, 2013
Recall Number Z-2325-2012
Recall Event ID 62852
Premarket Notification
510(K) Number
K092745 
Product Classification Indicator, Sterilization - Product Code LRT
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.
Code Information Product code KCT; Lot number: 60263
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Lindsey M. McGowan
440-392-7519
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LRT and Original Applicant = STERIS CORPORATION
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