Smiths Medical ASD Inc.: CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

Recall number

Z-0963-2023

Recalling firm

Smiths Medical ASD Inc.

Product

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

Status

Open, Classified

Initiated

2022-12-09

Posted

2023-01-30

Terminated

not on file

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

Root cause

Under Investigation by firm

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 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

Quantity

45285351 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

Lot, serial or model codes

1) REF 21-7300-24, UDI/DI 30610586027196, Lot numbers: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7321-24, UDI/DI 30610586029633, Lot numbers: 3773534 through 4308545; 5) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 6) REF 21-7323-24, UDI/DI 061058603961, Lot numbers: 3776373 through 4334325; 7) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 8) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 9) REF 21-7336-24, UDI/DI 30610586027295, Lot numbers: 3776360 through 4025381; 10) REF 21-7339-24, UDI/DI 30610586027301, Lot numbers: 3780565 through 4009665; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 13) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 14) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 15) REF 21-7390-24, UDI/DI 30610586027509, Lot numbers: 3780548 through 4334346; 16) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 17) REF 21-7394-24, UDI/DI 30610586027530, Lot numbers: 3774739 through 4339178; 18) REF 21-7395-24, UDI/DI 30610586027547, Lot numbers: 3808536 through 4308562 19) REF 21-7301-24JP, UDI/DI N/A , Lot numbers: 3630747 through 4334113; 20) REF 21-7302-24JP, UDI/DI N/A , Lot numbers: 3617363 through 4329630; 21) REF 21-7321-24JP, UDI/DI N/A , Lot numbers: 3773534 through 4308545; 22) REF 21-7322-24JP, UDI/DI N/A , Lot numbers: 3776375 through 4334324; 23) REF 21-7359-24JP, UDI/DI N/A , Lot numbers: 3776315 through 4334339; 24) REF 21-7394-24JP, UDI/DI N/A , Lot numbers: 3774739 through 4339178.

510(k) numbers

["K040636","K170982"]

PMA numbers

not on file

Product code

FPA

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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