Smiths Medical ASD Inc.: Medical Device Recall in 2023 - (Recall #: Z-0964-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

Product Classification:

Class I

Date Initiated: December 9, 2022

Date Posted: February 8, 2023

Recall Number: Z-0964-2023

Event ID: 91392

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

Status: Ongoing

Product Quantity: 726,878 units

Code Information:

a) REF 21-7308-24, UDI/DI 30610586032374, Lot Numbers: 4053922 through 4334076; b) REF 21-7309-24, UDI/DI 30610586032381, Lot Numbers: 4062405 through 4334085; c) REF 21-7310-24, UDI/DI 30610586032398, Lot Numbers: 4062404 through 4330874 d) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; e) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated