AMICUS Exchange Kit — Class II medical device recall Z-1523-2013
Terminated recall by Fenwal Inc, reported 2013-06-19, distributed nationwide. Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exch
| Recall number | Z-1523-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fenwal Inc, Lake Zurich, IL, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2013-06-08 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | FA12C07070 |
| Model numbers | R4R2339 |
| Expiration dates | 2014-03 |
Product
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Reason for recall
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
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-1523-2013. 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.