The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0966-2023·Announced 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.

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: This is classified as FDA Class I, which mandates a severity score of at least 4. Although no illnesses or deaths are reported in the source text, the potential for medication underdelivery in infusion systems poses significant patient risk.

Plain-English summary

Smiths Medical ASD Inc. is recalling CADD Administration Sets, which are used with computerized ambulatory infusion pumps to deliver medications to patients. The recall affects 33 different reference numbers and approximately 47.6 million units distributed worldwide.

The FDA classified this as a Class I recall due to two potential issues: (1) tubing occlusion that can prevent or reduce medication delivery to patients, and (2) false "No Disposable Attached" (NDA) alarms that may not accurately reflect the device status.

The affected units were distributed in the United States and to multiple countries including Canada, Australia, the United Kingdom, Japan, China, and many others. Patients and healthcare providers using affected CADD Administration Sets should contact Smiths Medical for instructions on device replacement or discontinuation.

Healthcare facilities and home infusion providers should immediately verify if they have affected units by checking the reference numbers and lot numbers listed on the FDA recall notice.

The recalled product

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…
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Device
Hazard
Affected units
47,595,495

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 (20)

  • 1) REF 21-7300-24
  • UDI/DI 30610586027196
  • Lot Number: 3630772 through 4334107
  • 2) REF 21-7301-24
  • UDI/DI 30610586027219
  • Lot numbers: 3630747 through 4334119
  • 3) REF 21-7302-24
  • UDI/DI 30610586027233
  • Lot numbers: 3617363 through 4334138
  • 4) REF 21-7308-24
  • UDI/DI 30610586032374
  • Lot numbers: 4053922 through 4334076
  • 5) REF 21-7309-24
  • UDI/DU 30610586032381
  • Lot numbers: 4062405 though 4334085
  • 6) REF 21-7310-24
  • UDI/DU 30610586032398
  • Lot numbers: 4062404 through 4330874
  • 7) REF 21-7322-24
  • UDI/DI 30610586029640

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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