Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Summary
The FDA issued a Class II for Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5 by Covidien, LP. Reason: This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU)..
Details
Source
Device Recall
External ID
Z-2358-2021
Action Date
2021-09-08
Status
Ongoing
Category
device
Product Description
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Lot/Code Info: Lot Numbers: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247
Quantity Affected: N/A
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-28
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2358-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29