Smiths Medical ASD Inc.: 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) R

Hazard

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

Details from the source

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: 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 Quantity: 45285351 units Lot/code info: 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: 363074

UPC codes

30610586027196, 30610586027219, 30610586027233, 30610586029633, 30610586029640, 061058603961, 30610586029657, 30610586043233, 30610586027295, 30610586027301, 35019517191824, 35019517184239, 30610586027400, 30610586027479, 30610586027509, 30610586027516, 30610586027530, 30610586027547

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.