Drug recall
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number…
FDA recall event 72416 · Class II · Covidien LLC
Key facts
| Event ID | 72416 |
|---|---|
| Recall numbers | Z-0329-2016, Z-0330-2016, Z-0331-2016, Z-0332-2016, Z-0333-2016 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic…, Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis…, Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for…, Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic…, Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrome chronic catheter is intended for acute and chronic… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrectly packaged with a 90 degree bend at the distal tip |
| Initiation date | Oct 14, 2015 |
| Report date | Dec 2, 2015 |
| Termination date | Jun 2, 2017 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
At a glance
- 1–9 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: