Smiths Medical ASD Inc.: Medical Device Recall in 2023 - (Recall #: Z-0962-2023)

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 21-7346-24; b) REF 21-7363-24

Product Classification:

Class I

Date Initiated: December 9, 2022

Date Posted: February 8, 2023

Recall Number: Z-0962-2023

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: 1616714 units

Code Information:

a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 3501951716196; Lot Numbers: 3773412 through 4334343;

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