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U.S. Department of Health and Human Services

Class 2 Device Recall Cannon II Plus Replacement Hub Set

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  Class 2 Device Recall Cannon II Plus Replacement Hub Set see related information
Date Initiated by Firm July 06, 2020
Create Date August 13, 2020
Recall Status1 Terminated 3 on November 05, 2021
Recall Number Z-2802-2020
Recall Event ID 86044
510(K)Number K020430  
Product Classification Kit, repair, catheter, hemodialysis - Product Code NFK
Product Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
Code Information Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Mario Wijker
353-90-6460865
Manufacturer Reason
for Recall		 The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.
Distribution World wide distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NFK and Original Applicant = DIATEK, INC.
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