Smiths Medical ASD Inc. CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
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
Products Sold
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;
Smiths Medical ASD Inc. is recalling CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 due to There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) Fal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
The firm issued an URGENT MEDICAL DEVICE CORRECTION notice on 12/09/2022 by mail. Actions for Clinicians and Patients: . The pump may not adequately detect the cassette before or during an infusion due to this issue, and an alarm will be triggered. If a pump displays an NDA alarm, the user can try to resolve the alarm by repositioning the CADD Medication Cassette Reservoir while connected to the pump, repositioning the reservoir by disconnecting from the pump and reattaching it to the pump, or replacing the reservoir. . Or the user can remove the reservoir from the pump and push the plastic ridge highlighted in the circle towards the arch on the reservoir. . For patients requiring life sustaining medications, we recommend use of alternative CADD infusion sets. Contact pharmacy to discuss availability of alternative CADD infusion sets. Due to availability and specific patient situations, clinicians may consider switching patients to an alternative pump. . If the user cannot resolve the NDA alarm, replace the cassette reservoir, though the issues may recur if that product is also affected by this recall. . Clinicians, share this letter with your homecare patients and educate them about the actions above. Complete and return the Response Form via fax at 866-338-4443 or email to smithsmedical5286@sedgwick.com. . DISTRIBUTORS: Immediately forward this notice to your customers them. Have them contact Sedgwick 866-562-5931(M-F, 8am-5pm ET) to obtain a response form. Global Complaint Management, globalcomplaints@smiths-medical.com 1-(866)-216-8806, Report adverse events or product complaints: Technical Assistance (800)-258-5361 . Pharmacists: . Immediately identify affected products in your possession. Separate and label them to avoid use for life sustaining medications. . For use with life sustaining medications, contact Smiths Medical customer service (800)-258-5361 for info on obtaining alternative CADD infusion sets. On 06/12/2023, another notification
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026