Reported Oct 30, 2024 · Ongoing

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Smiths Medical ASD 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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

  • ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Lot codes and dates
  • UDI/DI 30610586044179
  • Lot Numbers

    203 of 203 codes

    • 4010559AB
    • 4010560AB
    • 4010563AB
    • 4010573AB
    • 4016496AB
    • 4010561AB
    • 4010562AB
    • 4016490AB
    • 4010570AB
    • 4010569AB
    • 4016494AB
    • 4016497AB
    • 4010571AB
    • 4016491AB
    • 4010572AB
    • 4010574AB
    • 4016493AB
    • 4022630AB
    • 4025275AB
    • 4016492AB
    • 4016495AB
    • 4022621AB
    • 4022625AB
    • 4022628AB
    • 4006931AB
    • 4006933AB
    • 4006930AB
    • 4006932AB
    • 4022622AB
    • 4022623AB
    • 4022627AB
    • 4022624AB
    • 4022626AB
    • 4022632AB
    • 4022629AB
    • 4022631AB
    • 4025277AB
    • 4022633AB
    • 4022634AB
    • 4025274AB
    • 4022635AB
    • 4033938AB
    • 4033939AB
    • 4025281AB
    • 4033937AB
    • 4025278AB
    • 4025279AB
    • 4025280AB
    • 4033943AB
    • 4025288AB
    • 4025282AB
    • 4025289AB
    • 4025285AB
    • 4025286AB
    • 4025290AB
    • 4025287AB
    • 4033934AB
    • 4033928AB
    • 4030519AB
    • 4025291AB
Amount recalled
2881080 units

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

Why it was recalled

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:00 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.