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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

by Fresenius Kabi USA, LLC

510(k) K180615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180615 Date4 Dec 2018ClearedStatusActive

Recalls

4 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1255-2023 FDA Class II initiated 14 Feb 2023
    • Ongoing Z-1254-2023 FDA Class II initiated 14 Feb 2023

    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.

  • 2 recalls, same reason

    • Terminated Z-1344-2021 FDA Class II initiated 25 Feb 2021
    • Terminated Z-1345-2021 FDA Class II initiated 25 Feb 2021

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LKN
FDA applicant
Fresenius Kabi USA,Llc
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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