# FDA recall Z-0963-2023

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2022-12-09.

## 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,  13) REF 21-7359-24,  14) REF 21-7383-24,  15) REF 21-7390-24,  16) REF 21-7391-24,  17) REF 21-7394-24,  18) REF 21-7395-24,  19) REF 21-7301-24JP,  20) REF 21-7302-24JP,  21) REF 21-7321-24JP,  22) REF 21-7322-24JP,  23) REF 21-7359-24JP,  24) REF 21-7394-24JP

## Reason for recall

There are two potential issues with CADD Infusion  System Infusion Sets:  (1) Lack of Delivery or  Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

## Distribution

Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN

## Key facts

- **Recall number:** Z-0963-2023
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-09
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2023

## Citation

> AI Analytics. FDA recall Z-0963-2023. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0963-2023. Source: US FDA. Licensed CC0.

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