CADD Administration Set recall
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Why was CADD Administration Set 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 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
- Recall date
- February 8, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)