FDA Device recall Z-0366-2015
ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate woun…
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate woun… by Customed, citing significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0366-2015 |
| 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
ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Significant 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 140714524 |
|---|
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-0366-2015%22
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