McKesson 102-SN1C31516PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20612479187911), received between Apr 14, 2024 and Jun 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K151949, K993017); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER CLAIMS THAT ONE SINGLE PACKET OF SYRINGES WAS OPEN AND ALL 10 ORANGE CAPS WERE TAKEN OFF OF EACH SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465567 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE INSULIN LEAK FROM THE SYRINGE, A BIG PERCENTAGE IN A CASE HAVE THIS LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102893 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORT THAT BLUNT NEEDLES, PATIENTS COMPLAINED OF PAINFUL INJECTIONS; LEAKING SYRINGES; SYRINGES IN BOXES WITH PURPLE MARKINGS ON THE BOX AND PURPLE MARKINGS ON THE PACKAGE. THE PROBLEM WITH THIS IS THAT PURPLE IS THE COLOR OF BOTH THE 1CC BOX AND THE 1/2CC BOX, WHICH MAKES IT DIFFICULT TO DISTINGUISH WHEN USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102879 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151949, K993017. One submission often covers many models, so check the product and lot details in each record.

• Z-0119-2019 · Sep 4, 2018 · Terminated
  McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
• Z-3202-2018 · Aug 24, 2018 · Terminated
  Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly b
• Z-0569-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to b
• Z-0570-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21
• Z-0573-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21
• Z-0572-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21
• Z-0571-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21
• Z-0574-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21