# FDA recall Z-0965-2023

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

## 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

## 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-0965-2023
- **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-0965-2023

## Citation

> AI Analytics. FDA recall Z-0965-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0965-2023. Source: US FDA. Licensed CC0.

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