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Imc Piston Syringes

by International Medsurg Connection 510(k)

Active United States Open recall

510(k) K102969

Regulatory status

as of 29 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102969 Date20 Dec 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

40 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0939-2023 FDA Class II initiated 15 Dec 2022
    • Ongoing Z-0938-2023 FDA Class II initiated 15 Dec 2022

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

  • 38 recalls, same reason

    • Terminated Z-2851-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2857-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2830-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2854-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2856-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2842-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2846-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2862-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2836-201 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2831-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2844-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2839-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2858-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2828-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2840-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2853-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2847-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2829-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2843-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2832-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2850-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2827-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2845-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2860-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2837-201 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2848-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2834-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2859-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2852-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2825-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2861-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2833-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2849-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2835-201 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2841-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2826-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2855-2017 FDA Class II initiated 23 Jun 2017
    • Terminated Z-2838-201 FDA Class II initiated 23 Jun 2017

    Insufficient documentation to support product sterility claims.

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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