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Recall Observatory FDA recall evidence

Device product

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

Z-0962-2023

December 09, 2022

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 91392
Status
Ongoing
Classification
Class I
Quantity
1616714 units
Official record key
device-enforcement:Z-0962-2023

Official wording

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

Code information: a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 3501951716196; Lot Numbers: 3773412 through 4334343;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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