Class 2 Device Recall

• Date Initiated by Firm: December 02, 2020
• Create Date: January 21, 2021
• Recall Status: Terminated on June 21, 2022
• Recall Number: Z-0790-2021
• Recall Event ID: 86942
• 510(K)Number: K153540
• Product Classification: Wrap, sterilization - Product Code FRG
• Product: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883411
• Code Information: Lot Number: 200421A, 200521A
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: SAME; 440-392-7601
• Manufacturer Reason for Recall: Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) 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: Process control
• Action: Steris issued Urgent Medical Device Recall issued 12/2/20 to Distributors and Customers. Letter states reason for recall, health risk and action to take: 1.Please immediately inspect on-hand inventory for Vis-U-All High Temperature Sterilization Pouches and Tubing. For the full list of affected product and associated lots, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this Customer Notification Letter and destroy any remaining product in inventory. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. Your STERIS Sales Representative can assist you should you have any questions while completing the form. 3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963. If you have questions regarding this matter, please contact Tammy Gentry, Product Manager, at (440) 392-8625 or STERIS Customer Service at 1-800-548-4873.
• Quantity in Commerce: 53 cases
• Distribution: Nationwide Foreign:
• 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