Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
FDA Recall Z-0791-2021 · Posted None
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFRG
Date Initiated2020-12-02
Date Terminated2022-06-21
Product Quantity54 cases
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
Firm 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: [email protected] 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.
Root Cause
Process control
Distribution Pattern
Nationwide Foreign:
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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