Z-0794-2021Class II

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

Name: Z-0794-2021 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Creator: Steris Corporation
Published: 2020-12-02
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2020-12-02 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118 on 2020-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0794-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-02
Posted: 2021-01-21
Terminated: 2022-06-21
Recalling firm: STERIS Corporation
Product: Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Product code: FRG Wrap, Sterilization
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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.
Quantity in commerce: 589 cases
Distribution: Nationwide Foreign:
Product codes and lots: Lot Number: 200430A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0794-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0786-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0787-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0788-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0789-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0790-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0791-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0792-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0793-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0794-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0795-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0796-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0797-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0798-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07
Z-0799-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-13	2021-01-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)