The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0965-2023·Announced 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.

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 an FDA Class I recall, which per the rubric requires a minimum severity score of 4. No illnesses or injuries are documented in the source text. The classification of Severe reflects the critical role of the affected infusion system in delivering medications.

Plain-English summary

Smiths Medical ASD Inc. is recalling CADD Administration Sets (Reference numbers 21-7600-24, 21-7609-24, 21-7624-24, and 21-7649-24, and their JP variants) due to two potential safety issues affecting the infusion system.

The recalled sets may fail to deliver medication or deliver an insufficient amount due to tubing occlusion (blockage). Additionally, users may receive false 'No Disposable Attached (NDA)' alarm alerts from the infusion pump system. These issues could result in patients not receiving their prescribed medication or receiving incorrect dosages.

The recall affects 214,668 units and has worldwide distribution. Affected lot numbers range from 4072200 through 4334357, with specific lot ranges varying by product reference number.

Patients and healthcare providers should discontinue use of affected sets and contact Smiths Medical for replacement units. Healthcare facilities should verify which lots they have in inventory using the specific lot numbers provided by Smiths Medical.

The recalled product

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
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Pump / Infusion Set
Hazard
Affected units
214,668

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 (18)

  • a) REF 21-7600-24
  • UDI/DI 30610586044001
  • Lot Numbers: 4084914 through 4329633
  • b) REF 21-7609-24
  • UDI/DI 30610586044018
  • Lot Numbers: 4072200 through 4334090
  • c) REF 21-7624-24
  • UDI/DI 30610586044742
  • Lot Numbers: 4092506 through 4309481
  • d) REF 21-7649-24
  • UDI/DI 35019517184246
  • Lot Numbers: 4076410 through 4334357
  • e) REF 21-7600-24JP
  • UDI/DI N/A
  • f) REF 21-7609-24JP
  • g) REF 21-7624-24JP
  • h) REF 21-7649-24JP
  • Lot Numbers: 4076410 through 4334357.

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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