Recall Z-0744-2018— Steris Corporation

Name: FDA recall Z-0744-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-15

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2017-06-15, terminated 2018-07-17. It names one FDA 510(k) clearance: K153540. Product: Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs 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.. Reason: 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..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Terminated: 2018-07-17
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 Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs 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.

Reason for recall

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.

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