Z-1343-2021Class II

Amicus MNC Apheresis Kit - Double Needle -

Name: Z-1343-2021 Amicus MNC Apheresis Kit - Double Needle -
Creator: Fenwal Inc
Published: 2021-02-25
License: https://open.fda.gov/license/

Fenwal Inc / initiated 2021-02-25 / Terminated

FDA source

Fenwal Inc began a recall of Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells on 2021-02-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1343-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-25
Posted: 2021-04-02
Terminated: 2023-04-18
Recalling firm: Fenwal Inc
Product: Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Product code: GKT Separator, Automated, Blood Cell, Diagnostic
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.
FDA root cause: Under Investigation by firm
Action: A Recall notification letter titled, "URGENT - Medical Device Recall Amicus MNC Apheresis/Exchange Disposable Kits" and form titled, Amicus Therapeutic Kits Customer Reply Form were sent to consignees on 02/25/2021 via Fed Ex Overnight Express. The consignee requested their customers to: 1) Discontinue use of the affected products immediately by checking their inventory and quarantining all affected product at their facility. They were also informed to contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 for replacement kits to ensure additional procedures can continue. 2) Inform potential users of the product in their organization of this notification. 3) Based on the options listed below, complete the attached response form and return via the fax number, email address, or the enclosed Fed Ex envelope and return address. Option A: If there is no remaining inventory of the affected product complete the response form and return it to Fresenius Kabi. Option B: If the customer has affected product in inventory and wishes to return it: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 and request to return the affected product. They will assist the customer with placing a replacement order at that time. Option C: If the customer has a small number of kits in inventory and are willing to destroy the product on Fresenius Kabis behalf: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 to identify if the customer has product to be destroyed and require replacement. They will provide a certificate of destruction for completion. Once completed, the certificate should be returned to Fresenius Kabi and replacements will be sent. Customers may be in a position that no alternate Device is available and therefore choose to continue with the use of the affected Amicus MNC Apheresis kits or Amicus Exchange kits (Therapeutics kits). For such cases, the following actions should be put in place until replacement products a
Quantity in commerce: 4488 units
Distribution: 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.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1343-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1343-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-02
Z-1344-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-02
Z-1345-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-02

Product code GKT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)