Class II — Customed, Inc
| Recalling firm | CUSTOMED, INC. |
|---|---|
| Registered facility | CUSTOMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| Product | Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
| Quantity | 258 |
| Distribution | Distributed only in Puerto Rico. |
| Initiated | 2016-01-07 |
| Classified | 2016-04-14 |
| Terminated | 2017-05-03 |
| Recall number | Z-1418-2016 |
| 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 II recall — Customed, Inc (Z-1418-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72992/
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