Recall Z-0674-2025— Cardinal Health 200, LLC

Name: FDA recall Z-0674-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-01

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2024-11-01. It names one FDA 510(k) clearance: K160339. Product: Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL. Reason: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-11-01
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K160339 — Cardinal Health Isolation GownCardinal Health200, LLC·cleared 2016-07-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

Reason for recall

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

Data sourced from openFDA. This site is unofficial and independent of the FDA.