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Halyard 48521

by Owens & Minor Distribution, Inc.

Halyard 48521 is a Class II device made by Owens & Minor Distribution, Inc., cleared under FDA 510(k) K153540 on 4 Aug 2016 and listed in FDA GUDID since 5 May 2020 (UDI-DI 10885632243783), active as of 23 Oct 2026. 43 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

43 closed

Documents

510(k) K153540

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885632243783 UDI-DI Date5 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153540 Date4 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153540 decided 4 Aug 2016 Active
  • FDA GUDID UDI-DI 10885632243783 listed 5 May 2020 Listed

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.

Timeline

45 dated events

  1. Recall initiated FDA recalls Z-0796-2021
  2. Recall initiated FDA recalls Z-0789-2021
  3. Recall initiated FDA recalls Z-0795-2021
  4. Recall initiated FDA recalls Z-0798-2021
  5. Recall initiated FDA recalls Z-0791-2021
  6. Recall initiated FDA recalls Z-0797-2021
  7. Recall initiated FDA recalls Z-0799-2021
  8. Recall initiated FDA recalls Z-0790-2021
  9. Recall initiated FDA recalls Z-0786-2021
  10. Recall initiated FDA recalls Z-0793-2021

35 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Halyard
Generic name
Sterilization packaging, single-use
Model / reference
48521
Primary DI / UDI-DI
10885632243783
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K153540)

and 8 more cleared under K153540

Other devices from Owens & Minor Distribution, Inc.

See all devices from Owens & Minor Distribution, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)