The Recall Desk
SevereFDA (Devices)·Z-0963-2023·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA Class I classification indicates the product presents a reasonable probability of serious adverse health consequences. Although no illnesses or injuries have been reported, potential medication underdelivery and pump operation confusion warrant this severity level per FDA classification standards.

Plain-English summary

Smiths Medical ASD Inc. is recalling CADD Administration Sets used to deliver medication through infusion pumps. The recall affects 45,285,351 units distributed worldwide to the United States and 28 other countries. The products recalled include 24 reference numbers, each with specified lot number ranges.

The recall addresses two potential issues. First, the tubing in the administration set may become occluded (blocked), which could prevent or significantly reduce the delivery of medication to patients. Second, the devices may display false "No Disposable Attached" (NDA) alarms, which could create confusion about whether the infusion set is properly connected and the pump is operating correctly.

Affected products are identified by their reference numbers (REF 21-7300-24 through REF 21-7394-24JP) and specific lot number ranges. The complete list of affected products with lot numbers for each reference number is available from the FDA.

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 21-7321-24, 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,
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Infusion Sets / Administration
Hazard
  • tubing-occlusion
  • medication-underdelivery
  • false-nda-alarm

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 numbers: 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 21-7321-24
  • UDI/DI 30610586029633
  • Lot numbers: 3773534 through 4308545
  • 5) REF 21-7322-24
  • UDI/DI 30610586029640
  • Lot numbers: 3776375 through 4334324
  • 6) REF 21-7323-24
  • UDI/DI 061058603961
  • Lot numbers: 3776373 through 4334325
  • 7) REF 21-7324-24
  • UDI/DI 30610586029657

Distribution

Distributed nationwide across the United States.

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