CARDINAL HEALTH 01-9001ARecalls & reported problems

Cardinal Health 200, LLC · IV START 1624 1ML CHL · Class 2

Data updated Oct 18, 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 10887488176512), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Patient problems

Unspecified Tissue Injury1

Recent adverse event reports

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

MalfunctionSep 26, 2023
REGISTERED NURSE (RN) STARTING IV WENT TO CLEANSE FOREARM WITH CHLORAPREP. WHILE APPLYING CHLORAPREP APPLICATOR TO SKIN, RN PINCHED TUBES TO RELEASE FLUID INTO SKIN. SPONGE TOP FELL OFF AND GLASS SHARDS GRAZED SKIN SUPERFICIALLY. SKIN RE-CLEANSED AND BAND-AID APPLIED. DOCTOR AT BEDSIDE TO WITNESS.
Patient problems: Unspecified Tissue Injury
MAUDE report 17820648 ↗

Device details

UDI-DI	`10887488176512`
Brand	CARDINAL HEALTH
Model	01-9001A
Company	Cardinal Health 200, LLC
Product code	LRS · Kit, i.V. Start
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	In Commercial Distribution
Record updated	Mar 20, 2026

Device type (GMDN): General surgical procedure kit, medicated

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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