The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0962-2023·Announced 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.

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 mandates a minimum severity score of 4. The hazards—tubing occlusion causing medication delivery failure and false alarms in a critical infusion system—present serious patient safety risks that could result in patient harm.

Plain-English summary

Smiths Medical ASD Inc. is recalling CADD Infusion System Administration Sets, specifically List Numbers REF 21-7346-24 and REF 21-7363-24. The recall affects approximately 1.6 million units that have been distributed worldwide, including throughout the United States and internationally to countries such as Canada, the United Kingdom, Australia, Japan, and China.

The recalled administration sets have two potential safety issues. First, tubing occlusion (blockage) can occur within the sets, which may result in lack of medication delivery or underdelivery to patients receiving infusions. Second, the sets may display false "No Disposable Attached (NDA)" alarms, which could fail to alert healthcare providers to actual system problems and potentially compromise patient care.

Healthcare facilities, infusion centers, and patients using these administration sets should verify the lot numbers and product codes against the FDA notice. Contact Smiths Medical ASD Inc. for instructions regarding return, replacement, or discontinuation of affected units. Healthcare providers should monitor patients for any signs of medication delivery failure or unexplained alarm conditions.

The recalled product

Product
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Administration Set
Hazard
Affected units
1,616,714

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 (4)

  • a) REF 21-7346-24: UDI/DI 35019517161957
  • Lot Numbers: 3776356 through 4320785
  • b) REF 21-7363-24: UDI/DI 3501951716196
  • Lot Numbers: 3773412 through 4334343

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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