CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
FDA Recall #Z-0962-2023 — Class I — December 9, 2022
Product Description
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
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
Recalling Firm
Smiths Medical ASD Inc. — Minneapolis, MN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1616714 units
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
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated