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Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

by Safe Secure Packaging Co., Ltd.

510(k) K153540

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

43 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153540 Date4 Aug 2016ClearedStatusActive

Recalls

43 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-0788-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0792-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0794-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0796-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0789-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0795-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0798-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0791-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0797-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0799-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0790-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0786-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0793-2021 FDA Class II initiated 2 Dec 2020

    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

    • Terminated Z-0787-2021 FDA Class II initiated 2 Dec 2020

    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

  • 29 recalls, same reason

    • Terminated Z-0757-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0763-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0767-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0766-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0764-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0749-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0751-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0761-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0746-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0747-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0745-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0743-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0759-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0752-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0753-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0769-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0756-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0744-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0768-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0762-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0750-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0754-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0758-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0765-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0770-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0755-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0748-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0760-2018 FDA Class II initiated 15 Jun 2017
    • Terminated Z-0771-2018 FDA Class II initiated 15 Jun 2017

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRG
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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