Recall Z-2366-2021
Covidien, LP · initiated May 28, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Codes / lots: Lot Numbers: 1834500202 1920500219 2014900143 2020400107 1914800210 2009300121 2017500133 2023300110
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: Labeling design
Action taken
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
Details
- Recall number
- Z-2366-2021
- Initiated
- May 28, 2021
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Distribution
- Worldwide distribution.
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2358-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2359-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2360-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2361-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2362-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2363-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2364-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2365-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2367-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2368-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2369-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2370-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2371-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2372-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2373-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2374-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2375-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |