The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0964-2023·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification applies to this recall. While no deaths or reported injuries are mentioned in the source, the Class I designation indicates FDA determined the hazard—treatment delivery failure or failure to detect delivery failure—poses serious risk to patient health.

Plain-English summary

Smiths Medical ASD Inc. is recalling the CADD Administration Set (Computerized Ambulatory Delivery Device) used to deliver medications intravenously. The recall involves 726,878 units worldwide across five product variants with reference numbers 21-7308-24, 21-7309-24, 21-7310-24, 21-7308-24JP, and 21-7309-24JP.

The sets have two potential issues: tubing can become occluded, which may reduce or prevent medication delivery to the patient; and the device may generate false "No Disposable Attached" (NDA) alarms. These conditions could allow patients to receive insufficient or no medication despite believing they are receiving their prescribed treatment.

The sets were distributed worldwide including the United States, Canada, Europe, Australia, and Asia. Affected lot numbers range from 4053922 to 4334085 depending on the product variant.

Patients and healthcare providers using these sets should immediately check for signs of tubing occlusion and false alarm conditions. Contact Smiths Medical ASD Inc. or the FDA for guidance on replacement or corrective action.

The recalled product

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
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
726,878

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • a) REF 21-7308-24
  • UDI/DI 30610586032374
  • Lot Numbers: 4053922 through 4334076
  • b) REF 21-7309-24
  • UDI/DI 30610586032381
  • Lot Numbers: 4062405 through 4334085
  • c) REF 21-7310-24
  • UDI/DI 30610586032398
  • Lot Numbers: 4062404 through 4330874 d) REF 21-7308-24JP
  • UDI/DI N/A
  • Lot Numbers: 4053922 through 4334075
  • e) REF 21-7309-24JP
  • Lot Numbers: 4062405 through 4330870.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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