BIATAIN Alginate Ag

• FDA 510(k) K090453 decided 26 Feb 2009 Active
• FDA GUDID UDI-DI 05032749034447 listed 7 Dec 2022 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. 25 May 2022 Recall initiated FDA recalls Z-1806-2022
4. 25 May 2022 Recall initiated FDA recalls Z-1805-2022
5. 7 Dec 2022 Listed FDA GUDID 05032749034447

Trade name

Biatain

Generic name

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Model / Ref / Catalog

Alginate Ag, 376029980

Primary DI / UDI-DI

05032749034447

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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• MANUKA FILL by LINKS MEDICAL PRODUCTS, INC.
• TEGASORB(TM) ULCER DRESSING, #90-XXX by 3M COMPANY
• PolyMem Silver Surgical 1511 by Ferris Mfg. Corp.
• NEOSALUS by Quinnova Pharmaceuticals
• WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 by Blairex Laboratories, Inc.
• PHARMASEAL STERILE WOUND CARE DRESSING by Baxter Healthcare Corp
• SILVERSTREAM AND DERMASEPT by Enzysurge, Ltd.

• PHMB Foam Antimicrobial Wound Dressings

  Class III

  CE/MDR

• Scar Reduction Dressings

  Class I

  CE/MDR

• Biatain Alginate Ag - 20x30cm

  Class III

  CE/MDD

• 3M SILVERCEL Non-adherent Hydro-Alginate Antimicrobial Dressing - 5x5cm

  Class III

  CE/MDD

See all devices from Advanced Medical Solutions Limited →