CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Reported: February 8, 2023 Initiated: December 9, 2022 #Z-0962-2023
Product Description
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
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
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 1616714 units
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24. Recalled by Smiths Medical ASD Inc.. Units affected: 1616714 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Critical. Recall number: Z-0962-2023.
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