Amicus Exchange Kit Therapeutics. Component of Amicus… recallZ-1255-2023 · Fenwal Inc · initiated Feb 14, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Fenwal Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number: Z-1255-2023
Status: Open, Classified
Initiated by the company: Feb 14, 2023
Posted by the FDA: Mar 15, 2023
Recalling firm: Fenwal Inc
Quantity: 6,564 units
Product code: LKN
FDA submissions: K180615
Distribution: Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.

Product description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

AMICUS Exchange Kit - Therapeutics X6R2349
Fresenius Kabi AG · Separator, Automated, Blood Cell And Plasma, Therapeutic
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91704).

Z-1254-2023 · Open, Classified
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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