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Refurbished BG 323 Pump System 100-517PXSR

by Cme America LLC

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 NumberB101100517PXSR0 UDI-DI Date15 Sep 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 on shared 510(k) K042696
    • Terminated Z-2560-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2554-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2575-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2559-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2577-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2562-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2579-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2571-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2585-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2587-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2580-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2555-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2567-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2553-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2588-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2586-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2558-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2569-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2574-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2581-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2561-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2565-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2582-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2578-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2557-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2576-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2566-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2564-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2556-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2570-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2563-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2589-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2583-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2572-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2573-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696
    • Terminated Z-2584-2020 FDA Class I initiated 16 Jun 2020 on shared 510(k) K042696

    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

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

    • Terminated Z-1442-2020 FDA Class I initiated 16 Sep 2019

    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

    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
Refurbished BG 323 Pump System
Generic Name
Bedside infusion pump, single-channel
Model / Reference
100-517PXSR
Primary DI / UDI-DI
B101100517PXSR0
510(k) Number
FDA Product Code
MEA, FRN
GMDN Term
Bedside infusion pump, single-channel
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No