Recall Z-0879-2022— DeRoyal Industries Inc

Name: FDA recall Z-0879-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-03

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2022-03-03, terminated 2022-09-15. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.. Reason: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2022-03-03
Terminated: 2022-09-15
Firm location: Powell, 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 Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

Reason for recall

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

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