Recall Z-1832-2021— DeRoyal Industries Inc

Name: FDA recall Z-1832-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-14

Class I · Terminated

Class I FDA medical device recall by DeRoyal Industries Inc, initiated 2021-05-14, terminated 2023-04-21. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06. Reason: DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine.

Recalling firm: DeRoyal Industries Inc
Classification: Class I
Status: Terminated
Initiated: 2021-05-14
Terminated: 2023-04-21
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 Pacemaker Tray Pgybk, REF 89-6360.06

Reason for recall

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

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