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BodyGuard® Microset A100-163XES

by Cme America LLC 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

40 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB101A100163XES0 UDI-DI Date30 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

40 recalls · FDA

  • 37 recalls, same reason

    • Terminated Z-2568-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2560-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2554-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2575-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2559-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2577-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2562-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2579-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2571-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2585-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2587-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2580-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2555-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2567-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2553-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2588-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2586-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2558-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2569-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2574-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2581-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2561-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2565-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2582-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2578-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2557-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2576-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2566-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2564-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2556-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2570-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2563-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2589-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2583-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2572-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2573-2020 FDA Class I initiated 16 Jun 2020
    • Terminated Z-2584-2020 FDA Class I initiated 16 Jun 2020

    Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

    • Terminated Z-0305-2021 FDA Class II initiated 27 Feb 2020 on shared 510(k) K042696

    The wall charger may not properly charge the infusion pump battery.

    • Terminated Z-1442-2020 FDA Class I initiated 16 Sep 2019 on shared 510(k) K042696

    When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

    • Terminated Z-1126-2015 FDA Class II initiated 16 Jan 2015 on shared 510(k) K042696

    CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BodyGuard® Microset
Generic Name
Electric infusion pump administration set, single-use
Model / Reference
A100-163XES
Primary DI / UDI-DI
B101A100163XES0
510(k) Number
FDA Product Code
FPA
GMDN Term
Electric infusion pump administration set, single-use
Device Class
Class II
Regulation Number
880.5440
GUDID distribution status
Not in Commercial Distribution

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No