Class I — Customed, Inc
| Recalling firm | CUSTOMED, INC. |
|---|---|
| Registered facility | CUSTOMED, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 600 |
| Distribution | US Distribution to Florida, New York and Puerto Rico.. |
| Initiated | 2014-10-08 |
| Classified | 2014-11-28 |
| Terminated | 2017-08-14 |
| Recall number | Z-0409-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Customed, Inc (Z-0409-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69448/
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