Temno FRA2015Recalls & reported problems

Carefusion 2200, Inc · TEMNO FRANSEEN NEEDLE 20G X 15CM 10/CS · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403089558), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 17, 2022Material Twisted/Bent
CAREFUSION PRODUCT FRA2015, A FINE NEEDLE FOR ASPIRATION OPENED FOR A PROCEDURE HAD A CREASED BEND AND UNABLE TO USE DEVICE. A SECOND WAS OPENED FOR USE WITHOUT ANY BEND. NO HARM OR DELAY TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13548381 ↗

Device details

UDI-DI	`10885403089558`
Brand	Temno
Model	FRA2015
Company	Carefusion 2200, Inc
Product code	KNW · INSTRUMENT, BIOPSY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 2, 2023

Device type (GMDN): Cell-block cytology aspiration needle

A sterile, sharp bevel-edged, hollow tubular metal instrument, combined with a Luer connector containing an absorbent foam pad, intended to be used for the collection of a biopsy specimen by fine needle aspiration (FNA) and to enable cells in a fluid specimen to be incorporated into a cell block; it is not dedicated to a particular part of the anatomy. Cells from the aspirate are captured in the foam pad enabling processing and analysis of the specimen using techniques typically applied to solid tissue specimens (e.g., paraffin processing, histological sectioning, immunohistochemistry, in situ hybridization). 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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