• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall CADD Disposables

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall CADD Disposables see related information
Date Initiated by Firm December 09, 2022
Date Posted January 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-0965-2023
Recall Event ID 91392
510(K)Number K162219  
Product Classification Set, administration, intravascular - Product Code FPA
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
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/
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Sedgwick
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
Action The firm issued an "URGENT MEDICAL DEVICE CORRECTION" notice on 12/09/2022 by mail. The notice explained the problems and the potential risks, and requested the following: "Actions for Clinicians and Patients: " Be aware that 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 attempt 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. " Alternatively, the user can remove the reservoir from the pump and push the plastic ridge highlighted in the circle below towards the arch on the reservoir. " For patients requiring life sustaining medications, use of alternative CADD infusion sets is recommended. Contact pharmacy to discuss availability of alternative CADD infusion sets. Depending on 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. Customer Required Actions 1. Ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form via fax at 1-866-338-4443 or email to smithsmedical5286@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Ask them to contact Sedgwick at 1-866-562-5931(M-F, 8am-5pm ET) to obtain a response form." "Global Complaint Management, globalcomplaints@smith
Quantity in Commerce 7669060 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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = Smiths Medical ASD, Inc.