TELEFLEX IPN050863Recalls & reported problems

Teleflex Incorporated · Flocath Quick: Hydrophilic-coated catheter with 0.9% sterile saline solution · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 21
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04026704323883), received between Apr 20, 2023 and Oct 29, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (20 reports).

2 other recalls cover devices cleared under the same FDA submission (K000070); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Delivered as Unsterile Product20
Defective Device1

Patient problems

No Clinical Signs, Symptoms or Conditions20
Pain1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 29, 2024Defective Device; Defective Device
IT WAS REPORTED THAT "WHEN USING CATHETERS CUSTOMER NOTICE IT WAS ROUGH ON THE EDGE, WHEN HE USED THE CATHETER, IT CAUSED PAIN AND BLEEDING". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RESPONDED TO ANY REQUESTS FOR ADDITIONAL INFORMATION.
Patient problems: Pain
MAUDE report 20559529 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-202 3-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778617 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-202 3-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778512 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-202 3-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778405 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-202 3-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778188 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-202 3-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778134 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-202 3-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, AND 8040412-2023-00164.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778076 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-202 3-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778057 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-202 3-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778033 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-202 3-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16778010 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-202 3-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777971 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-202 3-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777908 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-202 3-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777891 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-202 3-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, AND 8040412-2023-00171.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777866 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-202 3-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, AND 8040412-2023-00172.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777850 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-202 3-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777831 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-202 3-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175, AND 8040412-2023-00174.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777804 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-202 3-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176, 8040412-2023-00175.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777775 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-202 3-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158, 8040412-2023-00176.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777687 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-202 3-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777653 ↗
MalfunctionApr 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171, 8040412-2023-00170, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-202 3-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-2023-00158.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000070. One submission often covers many models, so check the product and lot details in each record.

Z-2086-2019 · Jul 1, 2019 · Terminated
Rusch EasyCath Kit
Z-1732-2014 · May 21, 2014 · Terminated
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and

Device details

UDI-DI	`04026704323883`
Brand	TELEFLEX
Model	IPN050863
Catalog no.	220400140
Company	Teleflex Incorporated
Product code	KOD · CATHETER, UROLOGICAL
Class	Class 2
FDA submission	K000070
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 18, 2023

Device type (GMDN): Single-administration urethral drainage catheter

A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page