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U.S. Department of Health and Human Services

Class 2 Device Recall Sterilization Wrap

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  Class 2 Device Recall Sterilization Wrap see related information
Date Initiated by Firm June 15, 2017
Create Date February 27, 2018
Recall Status1 Terminated 3 on July 17, 2018
Recall Number Z-0764-2018
Recall Event ID 79100
510(K)Number K153540  
Product Classification Wrap, sterilization - Product Code FRG
Product Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case

Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Code Information Model# 884122 Lot# 161231A
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Mrs. Lindsay Gaffga
440-392-7521
Manufacturer Reason
for Recall		 On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.
FDA Determined
Cause 2		 Component change control
Action Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873.
Quantity in Commerce 39
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRG and Original Applicant = SAFE SECURE PACKAGING CO., LTD
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