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U.S. Department of Health and Human Services

Class 2 Device Recall PowerTrialysis ShortTerm Alphacurve Dialysis Catheter

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  Class 2 Device Recall PowerTrialysis ShortTerm Alphacurve Dialysis Catheter see related information
Date Initiated by Firm September 16, 2019
Create Date November 05, 2019
Recall Status1 Terminated 3 on June 29, 2020
Recall Number Z-0285-2020
Recall Event ID 83886
510(K)Number K133456  
Product Classification Catheter, hemodialysis, triple lumen, non-implanted - Product Code NIE
Product 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023

Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
Code Information REDR0440
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact BD Recall Coordinator
800-290-1689
Manufacturer Reason
for Recall		 A portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
FDA Determined
Cause 2		 Under Investigation by firm
Action On September 16, 2019, the firm distributed Urgent Medical Device Recall notices to affected customers. Customers were asked to take the following actions: 1. Immediately examine your inventory for the product code and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Please share this recall notification with all users of the product to ensure they are also aware of the recall. 3. Complete the Customer Response Form (even if you do not have affected lots in your inventory) and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement or credit. 4. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. The firm will provide product replacement or credit for all discarded inventory. If you have any questions or require assistance with the return of the recalled product please contact our recall coordinator at 1-800-290-1689 between 8 AM and 5 PM MST Monday through Friday.
Quantity in Commerce 75 units
Distribution Distributed to healthcare facilities in AR, FL, IL, NJ, TX, and WI.
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 = NIE and Original Applicant = C.R. BARD, INC.
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