Food, drugs, devices › Covidien, LP
Device recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Covidien, LP (North Haven, CT) initiated this device recall on 28 May 2021; FDA lists 18 product records under event 88250, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Covidien, LP has 31 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien, LP, North Haven, CT.
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)."
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2358-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2359-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2360-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2361-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2362-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2363-2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2364-2021 | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2365-2021 | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2366-2021 | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2367-2021 | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2368-2021 | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2369-2021 | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2370-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2371-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2372-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2373-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2374-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P | N/A | Class II | Ongoing | 8 Sep 2021 |
| Z-2375-2021 | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P | N/A | Class II | Ongoing | 8 Sep 2021 |
Context
Other enforcement events for Covidien, LP
All 31 events for Covidien, LP
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.