CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24...
FDA Device Recall #Z-0966-2023 — Class I — December 9, 2022
Recall Summary
| Recall Number | Z-0966-2023 |
| Classification | Class I — Serious risk |
| Date Initiated | December 9, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smiths Medical ASD Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 47595495 units |
Product Description
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) 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 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
Lot / Code Information
1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7308-24, UDI/DI 30610586032374, Lot numbers: 4053922 through 4334076; 5) REF 21-7309-24, UDI/DU 30610586032381, Lot numbers: 4062405 though 4334085; 6) REF 21-7310-24, UDI/DU 30610586032398, Lot numbers: 4062404 through 4330874; 7) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 8) REF 21-7323-24, UDI/DI 30610586039618, Lot numbers: 3776373 through 4334325; 9) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 10) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7346-24, UDI/DI 35019517161957, Lot numbers: 3776356 through 4320785; 13) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 14) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 15) REF 21-7363-24, UDI/DI 35019517161964, Lot numbers: 3773412 through 4334343; 16) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 17) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 18) REF 21-7394-24, UDI/DI 30610586027530, Lot number: 3774739 through 4339178; 19) REF 21-7600-24, UDI/DI 30610586044001, Lot numbers: 4084914 through 4329633; 20) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; 21) REF 21-7624-24, UDI/DI 30610586044742, Lot numbers: 4092506 through 4309481; 22) REF 21-7649-24, UDI/DI 35019517184246, Lot numbers: 4076410 through 4334357. 23) REF 21-7301-24JP, UDI/DI N/A, Lot Numbers: 3630747 through 4334113; 24) REF 21-7302-24JP, UDI/DI N/A, Lot Numbers: 3617363 through 4329630; 25) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; 26) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870; 27) REF 21-7322-24JP, UDI/DI N/A, Lot Numbers: 3776375 through 4334324; 28) REF 21-7359-24JP, UDI/DI N/A, Lot Numbers: 3776315 through 4334339; 29) REF 21-7394-24JP, UDI/DI N/A, Lot Numbers: 3774739 through 4339178; 30) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633; 31) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; 32) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; 33) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.
Other Recalls from Smiths Medical ASD Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0147-2025 | Class II | smiths medical portex, Thermovent 1200, 15mm/22... | Jul 18, 2024 |
| Z-0145-2025 | Class II | smiths medical portex, Y' PIECE 15MM, REF 100/2... | Jul 18, 2024 |
| Z-0146-2025 | Class II | smiths medical portex, 'ORATOR' SPEAKING VALVE ... | Jul 18, 2024 |
| Z-0143-2025 | Class II | smiths medical portex, Nasopharyngeal Airway, S... | Jul 18, 2024 |
| Z-0144-2025 | Class II | smiths medical portex, 15mm Double Swivel Conne... | Jul 18, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.