Recall archive / FDA device enforcement
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) ... — FDA record Z-0963-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP
- Reason
- 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
- Classification
- Class I
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 45285351 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0963-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) REF 21-7300-24, UDI/DI 30610586027196, Lot numbers: 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 21-7321-24, UDI/DI 30610586029633, Lot numbers: 3773534 through 4308545; 5) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 6) REF 21-7323-24, UDI/DI 061058603961, Lot numbers: 3776373 through 4334325; 7) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 8) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 9) REF 21-7336-24, UDI/DI 30610586027295, Lot numbers: 3776360 through 4025381; 10) REF 21-7339-24, UDI/DI 30610586027301, Lot numbers: 3780565 through 4009665; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 13) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 14) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 15) REF 21-7390-24, UDI/DI 30610586027509, Lot numbers: 3780548 through 4334346; 16) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 17) REF 21-7394-24, UDI/DI 30610586027530, Lot numbers: 3774739 through 4339178; 18) REF 21-7395-24, UDI/DI 30610586027547, Lot numbers: 3808536 through 4308562 19) REF 21-7301-24JP, UDI/DI N/A , Lot numbers: 3630747 through 4334113; 20) REF 21-7302-24JP, UDI/DI N/A , Lot numbers: 3617363 through 4329630; 21) REF 21-7321-24JP, UDI/DI N/A , Lot numbers: 3773534 through 4308545; 22) REF 21-7322-24JP, UDI/DI N/A , Lot numbers: 3776375 through 4334324; 23) REF 21-7359-24JP, UDI/DI N/A , Lot numbers: 3776315 through 4334339; 24) REF 21-7394-24JP, UDI/DI N/A , Lot numbers: 3774739 through 4339178. |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 8, 2023
- Recall initiation date
- Dec 9, 2022
- Center classification date
- Jan 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.