Z-1415-2020Class II

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack...

Name: Z-1415-2020 DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack...
Creator: Deroyal Industries, Inc. Lafollette
Published: 2020-02-04
License: https://open.fda.gov/license/

Deroyal Industries, Inc. Lafollette / initiated 2020-02-04 / Terminated / root cause: manufacturing process

FDA source

Deroyal Industries, Inc. Lafollette began a recall of DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13 on 2020-02-04. FDA classified it as Class II and gives the reason as "Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination". 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-1415-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-04
Posted: 2020-02-19
Terminated: 2021-04-01
Recalling firm: Deroyal Industries, Inc. Lafollette
Product: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Product code: LRO General Surgery Tray
Reason for recall: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.
Quantity in commerce: 2100 units
Distribution: US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Product codes and lots: Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1415-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1410-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1411-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1412-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1413-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1414-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1415-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1416-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1417-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1418-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28
Z-1419-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)