FDA Device recall Z-0409-2015
C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals…
- FDA Device
- Class I
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class I recall of C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals… 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-0409-2015 |
| 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
C-Section Surgical Pack, Catalog # 900-921A 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 140513148 140513469 140613849 140714552 140814963 |
|---|
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-0409-2015%22
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