Z-0965-2023Class I

CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF...

Name: Z-0965-2023 CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF...
Creator: Smiths Medical ASD Inc.
Published: 2022-12-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-12-09 / Open, Classified

FDA source

Smiths Medical ASD Inc. began a recall of CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g)... on 2022-12-09. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0965-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-12-09
Posted: 2023-01-30
Recalling firm: Abbott Medical
Product: CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Product code: FPA Set, Administration, Intravascular
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
FDA 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 [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
Quantity in commerce: 214668 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
Product codes and lots: a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914 through 4329633; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4092506 through 4309481; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4076410 through 4334357; e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633, f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; h) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0962-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-0963-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-0964-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-0965-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30
Z-0966-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30

Product code FPA

K162219Class IICADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. / cleared 2017-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)