AMICUS Exchange Kit recallZ-1523-2013 · Fenwal Inc · initiated May 24, 2013
Class II Terminated All recalls posted in June 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fenwal Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process change control
What the company is doing
Fenwal sent an Urgent Product Recall letter dated May 24, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately check inventory, discontinue the use of this prod.uct, return the affected product to Fenwal, and complete and return the attached reply form. For questions call 1-800-333-6925.
Recall details
- Recall number
- Z-1523-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 24, 2013
- Posted by the FDA
- Jun 8, 2013
- Recalling firm
- Fenwal Inc
- Quantity
- 19 Cases (114 Units)
- Product code
- LKN
- FDA submissions
- K111702
- Distribution
- USA Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
Other devices under the same FDA submission
1 device cleared under K111702 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AMICUS Exchange Kit X6R2339Fresenius Kabi AG · Separator, Automated, Blood Cell And Plasma, Therapeutic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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