Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff… — Class II medical device recall Z-1483-2016
Terminated recall by Customed, Inc, reported 2016-04-20, distributed in PR. Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity
| Recall number | Z-1483-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2016-01-07 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-05-03 |
| Distributed | PR |
| Quantity | 1,920 |
| Reason classes | sterility, packaging |
| Lot numbers | SL15203 |
| Model numbers | 900633FAN |
Product
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
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-1483-2016. 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.