Recall Z-1039-2020— Cardinal Health

Name: FDA recall Z-1039-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-11

Class II · Terminated

Class II FDA medical device recall by Cardinal Health, initiated 2020-01-11, terminated 2023-01-19. It names one FDA 510(k) clearance: K170762. Product: AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585. Reason: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination..

Recalling firm: Cardinal Health
Classification: Class II
Status: Terminated
Initiated: 2020-01-11
Terminated: 2023-01-19
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170762 — Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC·cleared 2017-06-09

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

AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585

Reason for recall

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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