FDA Recall Open, Classified

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device

Recall: Z-0966-2023 · Initiated December 9, 2022

Recall

Recall Number: Z-0966-2023
Event Number: 91392
Firm: Smiths Medical ASD Inc.
FEI Number: 3012307300
Product Code: FPA
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: December 9, 2022
Posted: January 30, 2023
Address: 6000 Nathan Ln N, Minneapolis, MN, 55442-1690

Description

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

Action

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 [email protected]. . 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, [email protected] 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

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

47595495 units