CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report
Amicus Exchange Kit recalled by Fenwal
Fenwal is recalling Amicus Exchange Kit, distributed nationwide in the US. The recall was initiated on 24 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1523-2013
- FDA event ID
- 65296
- Recalling firm
- Fenwal, Lake Zurich, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2013
- FDA classified
- 8 Jun 2013
- Reported
- 19 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 24 May 2013 | Recall initiated by company | |
| 8 Jun 2013 | Classified by FDA | +15 days |
| 19 Jun 2013 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Is Amicus Exchange Kit recalled?
Yes. Fenwal recalled Amicus Exchange Kit on 24 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1523-2013.
Why was it 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
Which lots are affected?
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
Where was it sold?
USA Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fenwal
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|---|---|---|---|---|---|
| Device | CLASS II | Amicus MNC Apheresis Kit Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit Therapeutics recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit Therapeutics recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus MNC Apheresis Kit - Double Needle recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
| Device | CLASS II | Amicus Exchange Kit recalled by Fenwal | Fenwal | Packaging Defects | Nationwide |
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