DeRoyal Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1833-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

Product Classification:

Class I

Date Initiated: May 14, 2021

Date Posted: June 16, 2021

Recall Number: Z-1833-2021

Event ID: 87949

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

Status: Terminated

Product Quantity: 66 packs

Code Information:

Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022

Distribution Pattern:

US Nationwide distribution to the states of MS, VA, LA, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated