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U.S. Department of Health and Human Services

Class 1 Device Recall CADD Disposables

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 Class 1 Device Recall CADD Disposablessee related information
Date Initiated by FirmDecember 09, 2022
Date PostedJanuary 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0965-2023
Recall Event ID 91392
510(K)NumberK162219 
Product Classification Set, administration, intravascular - Product Code FPA
ProductCADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24. Computerized Ambulatory Delivery Device
Code Information a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914, 4207430, 4230865, 4235211, 4271157; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4122844, 4146562, 4170226, 4271139; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4163669, 4185823, 4207870, 4227767, 4230898, 4248661, 4268054; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4120093, 4158808, 4163670, 4217360, 4256989.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactSedgwick
866-562-5931
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce68,797 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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