Z-1255-2023Class II

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Name: Z-1255-2023 Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Creator: Fenwal Inc
Published: 2023-02-14
License: https://open.fda.gov/license/

Fenwal Inc / initiated 2023-02-14 / Open, Classified / root cause: manufacturing process

FDA source

Fenwal Inc began a recall of Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform on 2023-02-14. FDA classified it as Class II and gives the reason as "Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1255-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-03-15
Recalling firm: Fenwal Inc
Product: Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Reason for recall: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.
Quantity in commerce: 6,564 units
Distribution: Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Product codes and lots: Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1255-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1254-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15
Z-1255-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-15

Product code LKN

K180615UnclassifiedAMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc / cleared 2018-12-04

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)