FDA Device recall Z-1523-2013
AMICUS Exchange Kit
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of AMICUS Exchange Kit by Fenwal, citing 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 Prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1523-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-24 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fenwal |
| Distribution | US |
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
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
Identifiers
| code_info | Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1523-2013%22
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