Date Initiated by Firm | May 28, 2021 |
Create Date | August 27, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2374-2021 |
Recall Event ID |
88250 |
510(K)Number | K123196 |
Product Classification |
Catheter, hemodialysis, implanted - Product Code MSD
|
Product | Palindrome 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 Contact | Catherine 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 |
Action | A 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 |
Distribution | Worldwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MSD
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