CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recalled

Deroyal Industries, Inc. Lafollette is recalling DeRoyal Sterile Custom Kits containing Cardinal Health Gowns, distributed in New Jersey, Rhode Island. The recall was initiated on 4 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Chronic Ear Pack 89-4393.17, Lot number: 49241024 exp. 07/01/2020;

Quantity recalled2100 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1411-2020
FDA event ID: 84889
Recalling firm: Deroyal Industries, Inc. Lafollette, La Follette, TN
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2020
FDA classified: 28 Feb 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Masks, Gloves & PPE

Timeline

4 Feb 2020	Recall initiated by company
28 Feb 2020	Classified by FDA	+24 days
11 Mar 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Product as listed by the FDA

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17

Where it was distributed

US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

New Jersey Rhode Island

Questions about this recall

Is DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recalled?

Yes. Deroyal Industries, Inc. Lafollette recalled DeRoyal Sterile Custom Kits containing Cardinal Health Gowns on 4 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1411-2020.

Why was it recalled?

Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Which lots are affected?

Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Chronic Ear Pack 89-4393.17, Lot number: 49241024 exp. 07/01/2020;

Where was it sold?

US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Deroyal Industries, Inc. Lafollette

All 12

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021Device	CLASS I	DeRoyal Procedure Packs containing Smiths Medical Normoflo recalled	Deroyal Industries, Inc. Lafollette	Other	FL, SC
25 Mar 2020Device	CLASS II	Teleflex Pilling Aortic Punch Sterile recalled	Deroyal Industries, Inc. Lafollette	Sterility	Nationwide
11 Mar 2020Device	CLASS II	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recalled	Deroyal Industries, Inc. Lafollette	Particulate Matter	NJ, RI
11 Mar 2020Device	CLASS II	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recalled	Deroyal Industries, Inc. Lafollette	Particulate Matter	NJ, RI
11 Mar 2020Device	CLASS II	DeRoyal Sterile Custom Kits containing Cardinal Health Gowns recalled	Deroyal Industries, Inc. Lafollette	Particulate Matter	NJ, RI

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