The Recall Desk

FDA (Devices) recall action 91392

Smiths Medical ASD Inc. recalled 5 products on 2023-02-08

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2023-02-08
Critical
0
Units
95,439,106

Why these products were recalled

There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • SevereFDA (Devices)··2023-02-08

    CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms

    Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2023-02-08

    CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms

    Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24,
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2023-02-08

    CADD Administration Sets recall for delivery failure and false alarms

    Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2023-02-08

    CADD Administration Set recall: medication underdelivery and false alarms

    Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
    Category
    Distribution
    4 states
  • SevereFDA (Devices)··2023-02-08

    CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms

    FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
    Category
    Distribution
    4 states