Smiths Medical ASD Inc.: CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24J

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: 214668 units Lot/code info: a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914 through 4329633; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4092506 through 4309481; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4076410 through 4334357; e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633, f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; h) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.

UPC codes

30610586044001, 30610586044018, 30610586044742, 35019517184246

Source

Official record: FDA (Device enforcement) ↗

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