CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report

GS0008 2Y - Burn Pack - STL recalled by ROi CPS

ROi CPS is recalling GS0008 2Y - Burn Pack - STL, distributed in Missouri. The recall was initiated on 11 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

Quantity recalled103 kits

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-0070-2024
FDA event ID: 93077
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2023
FDA classified: 5 Oct 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Sep 2023	Recall initiated by company
5 Oct 2023	Classified by FDA	+24 days
11 Oct 2023	Published in enforcement report	+6 days

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

Reason for recall

Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

Product as listed by the FDA

GS0008 2Y - Burn Pack - STL, Item Number 880082025

Where it was distributed

Missouri

Questions about this recall

Is GS0008 2Y - Burn Pack - STL recalled?

Yes. ROi CPS recalled GS0008 2Y - Burn Pack - STL on 11 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0070-2024.

Why was it recalled?

Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

Which lots are affected?

UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16

Where was it sold?

Missouri

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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