McKesson 16-SNT1C2558Recalls & reported problems

Mckesson Medical-Surgical Inc. · Syringe/NDL, TB, 1cc · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10612479207292), received between May 8, 2024 and Aug 27, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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.

Reports received per month

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

Most reported problems

Device problems

Leak/Splash2
Device Contaminated During Manufacture or Shipping1
Insufficient Device Problem Information1
Loose or Intermittent Connection1

Patient problems

No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
UPDATED ON SEPTEMBER 7, 2024: ON SEPTEMBER 3, 2024, WE RECEIVED 10 SAMPLES RETURNED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082276 ↗
MalfunctionAug 9, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES WERE LEAKING AND THAT THE CAPS WERE DIFFICULT TO REMOVE. TO REMOVE THE CAP, THE NEEDLE MUST BE HELD TIGHTLY, LOOSENING THE NEEDLE AND RESULTING IN LEAKAGE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955430 ↗
MalfunctionMay 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE CUSTOMER THAT FOREIGN MATTER WAS FOUND WITHIN THE SYRINGE.THE FOREIGN MATTER WAS ADHERED TO THE RUBBER STOPPER.NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS REPORTED ISSUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266483 ↗
MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT MEDICATION SPURTED AROUND THE NEEDLE CONNECTION AND INTO HER EYES AND FACE. SHE HAD TO GO TO THE EYE WASH STATION WHICH RESOLVED THE ISSUE. ON A SEPARATE OCCASION, THE SYRINGE CAME APART FROM THE NEEDLE WHEN REMOVING THE SYRINGE AFTER ADMINISTERING THE SHOT AND THE NEEDLE STAYED IN THE ARM AND WAS MANUALLY REMOVED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THESE REPORTED ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266392 ↗
MalfunctionMay 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
CUSTOMER STATED THE NEEDLES ARE FALLING OFF WHEN THEY START TO USE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266358 ↗

Device details

UDI-DI	`10612479207292`
Brand	McKesson
Model	16-SNT1C2558
Company	Mckesson Medical-Surgical Inc.
Product code	FMF · Syringe, Piston
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	Nov 24, 2025

Device type (GMDN): General-purpose syringe, single-use

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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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