FDA Device recall Z-0070-2024
GS0008 2Y - Burn Pack - STL, Item Number 880082025
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of GS0008 2Y - Burn Pack - STL, Item Number 880082025 by Roi Cps, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0070-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-11 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | MO |
Product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Reason
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.
Identifiers
| code_info | UDI/DI 10194717113805, Lot Number 97289, Exp Date 2025-07-16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Roi Cps
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Device · Class II · 2024-09-25 · Roi Cps - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2024%22
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