Extremity PACK — Class I medical device recall Z-0354-2015
Terminated recall by Customed, Inc, reported 2014-12-10, distributed in FL, NY, PR. Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the m
| Recall number | Z-0354-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2014-10-08 |
| Classified | 2014-11-28 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2017-08-14 |
| Distributed | FL, NY, PR |
| Quantity | 168 |
| Reason classes | sterility |
| Lot numbers | 140513135, 140613730, 140714256 |
| Model numbers | 900-2615 |
Product
Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0354-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.