Recall Z-0794-2021— Steris Corporation

Name: FDA recall Z-0794-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-02

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2020-12-02, terminated 2022-06-21. It names one FDA 510(k) clearance: K153540. Product: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118. Reason: 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.

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Terminated: 2022-06-21
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K153540 — Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.·cleared 2016-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.