Tegaderm™ 90303

• FDA 510(k) K090453 decided 26 Feb 2009 Active
• FDA GUDID UDI-DI 30707387583607 listed 27 Oct 2016 Listed

• 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

1. 26 Feb 2009 Cleared FDA 510(k) K090453
2. 15 Jan 2015 Recall initiated FDA recalls Z-2719-2016
3. 27 Oct 2016 Listed FDA GUDID 30707387583607
4. 25 May 2022 Recall initiated FDA recalls Z-1806-2022
5. 25 May 2022 Recall initiated FDA recalls Z-1805-2022

Trade name

Tegaderm™

Generic name

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Model / Ref / Catalog

90303

Primary DI / UDI-DI

30707387583607

510(k) Number

K090453 ↗

FDA product code

FRO

GMDN term

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Device class

U

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

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

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