Z-1523-2013Class II

AMICUS Exchange Kit

Name: Z-1523-2013 AMICUS Exchange Kit
Creator: Fenwal Inc
Published: 2013-05-24
License: https://open.fda.gov/license/

Fenwal Inc / initiated 2013-05-24 / Terminated / root cause: labeling and UDI

FDA source

Fenwal Inc began a recall of AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by... on 2013-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1523-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2013-06-08
Terminated: 2016-08-01
Recalling firm: Fenwal Inc
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.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
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
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 19 Cases (114 Units)
Distribution: USA Nationwide Distribution
Product codes and lots: Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-08

Product code LKN

K111702UnclassifiedAmicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc. / cleared 2012-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)