—#161353

Product

Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 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.

FDA product code: FRG — Wrap, Sterilization
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K153540
Affected lot / code info: Model# 883411 Lot# 161121A

Why it was recalled

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.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2017-06-15
Terminated: 2018-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161353. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.