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U.S. Department of Health and Human Services

Class 2 Device Recall Palindrome RT Chronic Catheter Kit Symmetrical Tip

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 Class 2 Device Recall Palindrome RT Chronic Catheter Kit Symmetrical Tipsee related information
Date Initiated by FirmMay 28, 2021
Create DateAugust 27, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2374-2021
Recall Event ID 88250
510(K)NumberK123196 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductPalindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Code Information Lot Numbers: 1729700119 1817700205 1910600266 2014900148 1810400147 1828900137 2014900151 2034400131
Recalling Firm/
Manufacturer
Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactCatherine Wrenn
203-492-5000
Manufacturer Reason
for Recall
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
FDA Determined
Cause 2
Labeling design
ActionA Medical Device Market Withdrawal notification letter dated 5/28/21 was sent to customers. Actions being taken by Medtronic 1. Medtronic is developing point-of-use labeling reinforcing the important user assembly steps contained within the IFU related to the hub/back end assembly procedure. 2. The IFU for Palindrome" RT and Palindrome" Precision RT chronic hemodialysis catheters will be updated to enhance the detailed instructions for users related to the steps required for hub/back end assembly. Actions you should take 1. Please immediately quarantine and discontinue use of affected item codes and lots listed in Attachment A. 2. Please return affected product as indicated below. All unused products from the affected item codes and lots must be returned. 3. If you have distributed the Palindrome" RT and Palindrome" Precision RT chronic hemodialysis catheters listed in Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Product Return Form even if you do not have inventory. Purchased directly from Medtronic 1. Complete the Product Return Form and fax or email to Medtronic. 2. Ship affected product with RGA number provided by Customer Service to: Medtronic Attn: Field Returns 195 McDermott Road North Haven, CT 06473 USA Fax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com Purchased from a distributor 1. Complete the Product Return Form and fax or email to Medtronic 2. Contact your distributor directly to arrange for return of product back to your distributor. Fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com This action is being taken with the knowledge of the FDA and other regulatory authorities. We request that you contact Medtronic if you experienced a quality problem or adverse event. Ema
DistributionWorldwide distribution.
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 = MSD
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