Reported Oct 6, 2021 · Terminated

Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System…

B. Braun Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512

Is this the product you have?

  • Outlook Pump Sets w/3
  • CARESITE Needle-Free Injection Sitessingle-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion
  • of parenteral fluids Material ID352413
Lot codes and dates
  • Lot Code
    • 0061755638
    • 0061757839
    • 0061759426
    • 0061763839
    • 0061763893
    • 0061763894
    • 0061766190
    • 0061767014
    • 0061767027
    • 0061768466
    • 0061769094
    • 0061772192
    • 0061772193
    • 0061775455
    • 0061776025
    • 0061776298
    • 0061776299
    • 0061776300
    • 0061776301
    • 0061777154
    • 00VL752555
    • 00VL754131
  • DI04046964182211
Amount recalled
585,576 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2024 · Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.