Fenwal Inc: Medical Device Recall in 2021 - (Recall #: Z-1343-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Product Classification:

Class II

Date Initiated: February 25, 2021

Date Posted: April 14, 2021

Recall Number: Z-1343-2021

Event ID: 87407

Reason for Recall:

Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

Status: Terminated

Product Quantity: 4488 units

Code Information:

Product Code X6R2326; UDI: 04086000100144; Batch Numbers FA20E25234 ((Exp. 05/31/2022), FA20F23120 (Exp. 06/30/2022), FA20I21268 (Exp. 09/30/2022), and FA20J19246 (Exp. 10/31/2022).

Distribution Pattern:

US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.

Voluntary or Mandated:

Voluntary: Firm initiated