—#184885

Product

Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713

FDA product code: FRG — Wrap, Sterilization
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K153540
Affected lot / code info: Lot Number: 200425A, 200625A

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Nationwide Foreign:

Timeline

Recall initiated: 2020-12-02
Terminated: 2022-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.