Recall Z-1981-2019— DeRoyal Industries Inc

Name: FDA recall Z-1981-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-18

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2019-06-18, terminated 2020-09-16. It names one FDA 510(k) clearance: K842648. Product: DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack. Reason: Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Terminated: 2020-09-16
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 THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack

Reason for recall

Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.

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