Recall Z-0637-2018— DeRoyal Industries Inc

Name: FDA recall Z-0637-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-22

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2018-01-22, terminated 2020-08-19. It names one FDA 510(k) clearance: K842648. Product: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy. Reason: DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2018-01-22
Terminated: 2020-08-19
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

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy

Reason for recall

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

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