Skip to content

McKesson 3560

by Mckesson Medical-Surgical Inc.

McKesson 3560 is a device classified as Unclassified made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K090453 on 26 Feb 2009 and listed in FDA GUDID since 9 Jan 2020 (UDI-DI 10612479193809), active as of 23 Oct 2026. 3 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

2 ongoing

This device is named in the recall

Documents

510(k) K090453

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 Number10612479193809 UDI-DI Date9 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK090453 Date26 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090453 decided 26 Feb 2009 Active
  • FDA GUDID UDI-DI 10612479193809 listed 9 Jan 2020 Listed

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1806-2022 FDA Class III initiated 25 May 2022
    • Ongoing Z-1805-2022 FDA Class III initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

    • Terminated Z-2719-2016 FDA Class II initiated 15 Jan 2015

    On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

Timeline

5 dated events

  1. Cleared FDA 510(k) K090453
  2. Recall initiated FDA recalls Z-2719-2016
  3. Listed FDA GUDID 10612479193809
  4. Recall initiated FDA recalls Z-1806-2022
  5. Recall initiated FDA recalls Z-1805-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
McKesson
Generic name
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Model / reference
3560
Primary DI / UDI-DI
10612479193809
510(k) Number
FDA product code
FRO
GMDN term
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Cleared under the same submission (K090453)

and 8 more cleared under K090453

Similar devices

Other devices filed under FDA product code FRO (Dressing, Wound, Drug).

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)