CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Centurion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin recalled

Centurion Medical Products is recalling Centurion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin Scrub Tray SP415 Sterile Gauze, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390

Quantity recalledN/A

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-1092-2020
FDA event ID: 84530
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 11 Dec 2019
FDA classified: 5 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

11 Dec 2019	Recall initiated by company
5 Feb 2020	Classified by FDA	+56 days
12 Feb 2020	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

Incomplete seals on the sterile package may compromise the sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE

Where it was distributed

Nationwide Foreign: GHANA

Nationwide

Questions about this recall

Is Centurion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin Scrub Tray SP415 Sterile Gauze recalled?

Yes. Centurion Medical Products recalled Centurion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin Scrub Tray SP415 Sterile Gauze on 11 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1092-2020.

Why was it recalled?

Incomplete seals on the sterile package may compromise the sterility

Which lots are affected?

Product/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390

Where was it sold?

Nationwide Foreign: GHANA

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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