Z-0749-2018Class II

Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case

Name: Z-0749-2018 Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Creator: Steris Corporation
Published: 2017-06-15
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2017-06-15 / Terminated / root cause: labeling and UDI

FDA source

Steris Corporation began a recall of Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable... on 2017-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0749-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Posted: 2018-02-27
Terminated: 2018-07-17
Recalling firm: STERIS Corporation
Product: Vis-U-All High Temp 4"x8" 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.
Product code: FRG Wrap, Sterilization
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.
Root cause tag: labeling and UDI
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 32
Distribution: US Nationwide Distribution
Product codes and lots: Model# 883048 Lot# 161116A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0749-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0743-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0744-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0745-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0746-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0747-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0748-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0749-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0750-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0751-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0752-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0753-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0754-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0755-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0756-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0757-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0758-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0759-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0760-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0761-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0762-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0763-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0764-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0765-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0766-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0767-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0768-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0769-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0770-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27
Z-0771-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code FRG

K153540Class IISafe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd. / cleared 2016-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)