Z-0964-2023 Class I Ongoing
FDA device recall Z-0964-2023 was initiated by Smiths Medical ASD Inc. on Dec 9, 2022 and is designated Class I. 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 The recall status is ongoing. Affected quantity: 726,878 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2023
- Initiation Date
- Dec 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 726,878 units
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
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 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
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0964-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026