Drug recall
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item…
FDA recall event 88250 · Class II · Covidien, LP
Key facts
| Event ID | 88250 |
|---|---|
| Recall numbers | Z-2358-2021, Z-2359-2021, Z-2360-2021, Z-2361-2021, Z-2362-2021, Z-2363-2021, Z-2364-2021, Z-2365-2021, Z-2366-2021, Z-2367-2021, Z-2368-2021, Z-2369-2021 and 6 more |
| Recalling firm | Covidien, LP |
| Product type | Devices |
| Products | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P, Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P, Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P, Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P, Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P and 13 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | May 28, 2021 |
| Report date | Sep 8, 2021 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: