CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report

DeRoyal Sterile Custom kits recalled by DeRoyal Industries

DeRoyal Industries is recalling DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a), distributed nationwide in the US. The recall was initiated on 16 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132

Quantity recalled5946 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-0199-2018
FDA event ID: 78517
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2017
FDA classified: 6 Dec 2017
Reported: 13 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Surgical Instruments

Timeline

16 Oct 2017	Recall initiated by company
6 Dec 2017	Classified by FDA	+51 days
13 Dec 2017	Published in enforcement report	+7 days

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

Reason for recall

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f) Plastic Pack, REF 89-7212.04 g) Plastic Pack, REF 89-7212.05 Product Usage: Custom surgical and procedural kits

Where it was distributed

US Nationwide distribution in the states of GA, IN, FL, and PA

Nationwide Florida Georgia Indiana Pennsylvania

Questions about this recall

Is DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) recalled?

Yes. DeRoyal Industries recalled DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) on 16 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0199-2018.

Why was it recalled?

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

Which lots are affected?

a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132

Where was it sold?

US Nationwide distribution in the states of GA, IN, FL, and PA

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.

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