Z-1833-2021Class I

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

Name: Z-1833-2021 DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Creator: DeRoyal Industries Inc
Published: 2021-05-14
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2021-05-14 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 on 2021-05-14. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1833-2021
Classification: Class I
Status: Terminated
Initiated: 2021-05-14
Posted: 2021-06-10
Terminated: 2023-04-21
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Product code: LRO General Surgery Tray
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by email on May 14, 2021. The notice explained the problem and hazard,. Customers were instructed to complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. and return to DeRoyal via fax to 865-362-3716 or [email protected] Customers were asked to PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. Distributors were instructed to notify their customers.
Quantity in commerce: 66 packs
Distribution: US Nationwide distribution to the states of MS, VA, LA, and NY.
Product codes and lots: Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1833-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10
Z-1833-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10
Z-1834-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)