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Concentrated Platelet Admin. Set

by American Mcgaw

510(k) K840212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840212 Date6 Mar 1984ClearedStatusActive

Recalls

8 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-0617-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0620-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0619-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0616-2026 FDA Class II initiated 29 Oct 2025

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

  • 4 recalls, same reason

    • Terminated Z-0937-2020 FDA Class II initiated 20 Nov 2019
    • Terminated Z-0936-2020 FDA Class II initiated 20 Nov 2019
    • Terminated Z-0940-2020 FDA Class II initiated 20 Nov 2019
    • Terminated Z-0938-2020 FDA Class II initiated 20 Nov 2019

    Potential for leakage at the joint between the blood filters and tubing

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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