Recall Z-1411-2020— Deroyal Industries, Inc. Lafollette

Name: FDA recall Z-1411-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-04

Class II · Terminated

Class II FDA medical device recall by Deroyal Industries, Inc. Lafollette, initiated 2020-02-04, terminated 2021-04-01. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17. Reason: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination..

Recalling firm: Deroyal Industries, Inc. Lafollette
Classification: Class II
Status: Terminated
Initiated: 2020-02-04
Terminated: 2021-04-01
Firm location: La Follette, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

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

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17

Reason for recall

Cardinal Health 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.