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CADD Administration Set, List Numbers recallZ-0965-2023 · Smiths Medical ASD Inc. · initiated Dec 9, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0965-2023
Status
Open, Classified
Initiated by the company
Dec 9, 2022
Posted by the FDA
Jan 30, 2023
Recalling firm
Smiths Medical ASD Inc.
Quantity
214668 units
Product code
FPA
FDA submissions
K162219
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 description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K162219 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91392).

Sources and updates

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