Fenwal Inc: Medical Device Recall in 2013 - (Recall #: Z-1523-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 24, 2013

Date Posted: June 19, 2013

Recall Number: Z-1523-2013

Event ID: 65296

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

Status: Terminated

Product Quantity: 19 Cases (114 Units)

Code Information:

Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated