FDA Device recall Z-0252-2015
Wound Management Tray II, Catalog number 900-1198
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of Wound Management Tray II, Catalog number 900-1198 by Customed, citing customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0252-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-10-08 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | FL, NY, PR |
Product
Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Identifiers
| code_info | Lot numbers: 111112987 112010275 112030830 112041392 112051737 112062338 112072827 112093746 113015492 113026…Lot numbers: 111112987 112010275 112030830 112041392 112051737 112062338 112072827 112093746 113015492 113026217 113047317 113068142 113109711 140111111 140312056 140513037 140714161 140915150 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0252-2015%22
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