TRUEplus TRUEplus SINGLE-USE INSULIN syringes 31 gauge needle 1.0cc insulinRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00021292005887), received between Nov 6, 2019 and Jan 27, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 reports).

8 other recalls cover devices cleared under the same FDA submission (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Product Quality Problem; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUE PLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL THEN BY TELEPHONE. PER THE CUSTOMER ONE OF SYRINGES HAS A GRAY GLOB OF PLASTIC AND WILL NOT ALLOW THE NEEDLE TO DRAW UP THE SYRINGES. CUSTOMER STATED HE WAS ABLE TO USE TWO OF THE SYRINGES SINCE THEN AND THEY WERE FINE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. PER THE CUSTOMER HE OPENED THE PACKAGE A WEEK BEFORE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196041 ↗
• MalfunctionAug 27, 2025Dull, Blunt; Dull, Blunt

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THE SYRINGE NEEDLES WERE DULL AND HARD TO PRESS INTO THE VIAL OF INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PRODUCT FOR A COUPLE OF WEEKS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED USING THE SYRINGES AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904391 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED SHE HAD ABOUT 3 SYRINGES THAT WERE BENT; CUSTOMER STATED SHE DID NOT USE THEM. CUSTOMER IS USING THE SYRINGES FOR THE FIRST TIME ON THE DAY OF THE CALL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721582 ↗
• MalfunctionMar 27, 2025Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER'S WIFE WAS CONTACTED BY TELEPHONE. CUSTOMER REPORTED THAT THE NEEDLES ON THE 31G SYRINGES WERE BENT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 2-3 WEEKS. CUSTOMER REPORTED THAT THEY HAD MADE 7 MULTI-BOX PURCHASES OF THE SYRINGES AND HAD 1 BOX LEFT; CALLER WAS CONCERNED ABOUT THE LAST BOX BECAUSE THERE WERE MORE OF THE SYRINGE NEEDLES BENT IN THAT PARTICULAR BOX. CALLER CONFIRMED THE CUSTOMER DID NOT USE THE BENT NEEDLES; ONCE THE PROTECTIVE COVER WAS REMOVED AND THEY HAD DETERMINED THEY WERE BENT, THEY HAD DISCARDED THOSE SYRINGES. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHEN USING THE SYRINGES AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708268 ↗
• MalfunctionNov 4, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE SYRINGES DID NOT ASPIRATE THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT SINCE (B)(6) 2024. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597996 ↗
• MalfunctionOct 8, 2024Break; Product Quality Problem; Break; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. DISTRIBUTOR/SUPPLIER REPORTED COMPLAINT ON BEHALF OF THE CUSTOMER VIA E-MAIL: REFERENCE CASE# (B)(4). CUSTOMER HAD REPORTED THAT THE SYRINGE CAPS WERE BROKEN AND THE NEEDLES WERE EXPOSED. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. MANUFACTURER ATTEMPTED TO CONTACT DISTRIBUTOR VIA TELEPHONE AND E-MAIL IN EFFORT TO OBTAIN ADDITIONAL INFORMATION; MANUFACTURER UNABLE TO MAKE CONTACT AT THIS TIME, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402249 ↗
• MalfunctionSep 11, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. CALLER STATED THAT SOME OF THE SYRINGES DO NOT DISPENSE THE INSULIN. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER HAS BEEN USING THE PRODUCT FOR 2 WEEKS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191837 ↗
• MalfunctionAug 8, 2024No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THEY ARE UNABLE TO ADMINISTER THEIR INSULIN. CARETAKER IS CALLING ON BEHALF OF THE CUSTOMER. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS IS THE FIRST TIME THE CUSTOMER USED THE PRODUCT OUT OF THIS PACKAGE. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE PEN NEEDLES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939332 ↗
• MalfunctionApr 11, 2024Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED HE HAD JUST OPENED THE BOX AND THE SYRINGE NEEDLES ARE BENT. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086205 ↗
• InjuryAug 30, 2023Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER REPORTED THAT ONE OF THE 31G SYRINGES DID NOT HAVE A CAP ON IT AND THE CUSTOMER HAD STUCK THEMSELVES WITH THE NEEDLE. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAD PURCHASED A NEW BOX OF SYRINGES AND PHARMACIST IS CALLING FOR REPLACEMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17652322 ↗
• MalfunctionJun 6, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES, STATING THAT THE 31G SYRINGES DID NOT DISPENSE THE INSULIN. CUSTOMER STATED THE SYRINGES ARE ABLE TO ASPIRATE THE INSULIN BUT THAT HE IS NOT ABLE TO INJECT IT. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER HAS BEEN USING THE PRODUCT FOR THE PAST TWO DAYS. CUSTOMER STATED HE HAD BEEN PREVIOUSLY USING THE 30G SYRINGES. CUSTOMER STATED THAT HE HAS NOT TAKEN HIS INSULIN FOR A FEW DAYS AND SO HE NEEDS THE SYRINGES TO WORK. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE INJURED WHILE USING THE SYRINGES AND NO MEDICAL INTERVENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070614 ↗
• MalfunctionMay 3, 2023No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED THAT THE 31G SYRINGES DID NOT PROPERLY DISPENSE THE INSULIN. CUSTOMER STATED THAT HE USED MULTIPLE SYRINGES ATTEMPTING TO ADMINISTER THE INSULIN. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER DID NOT CLAIM TO BE INJURED USING THE SYRINGES. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859797 ↗
• MalfunctionOct 21, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. CUSTOMER STATED THAT WHEN HE ATTEMPTS IN INJECT THE INSULIN, THE NEEDLE IS "BARBED", AND IT IS PAINFUL UPON INSERTION INTO THE SKIN AND WHEN PULLING THE SYRINGE OUT AFTER GIVING HIMSELF HIS DOSAGE. CUSTOMER STATED THAT HE HAS BEEN USING THE PRODUCT FOR MORE THAN ONE MONTH. CUSTOMER STATED THAT HE HAS NO SYRINGES LEFT AND THAT HE USED THE LAST ONE THIS MORNING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Pain

  MAUDE report 15650782 ↗
• MalfunctionFeb 22, 2022Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 31G SYRINGES. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. HUSBAND STATED WHEN THE CUSTOMER ATTEMPTED TO INJECT HER INSULIN THE NEEDLES ON THE SYRINGES WERE BENT. THIS IS NOT THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE; CUSTOMER HAS BEEN USING THE PRODUCT FOR THREE WEEKS. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576675 ↗
• MalfunctionFeb 16, 2022No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS SINGLE-USE INSULIN SYRINGES. DISTRIBUTOR AND PHARMACY REPORTED COMPLAINT ON BEHALF OF THE CUSTOMER. NO SYMPTOMS OR MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. PER PHARMACIST THE "SYRINGES WON¿T HOLD MEDICATION.¿ MANUFACTURER CONTACTED PHARMACIST. PHARMACIST DIDN¿T HAVE ALL THE DETAILS OF THE ISSUE AND DID NOT KNOW HOW MANY SYRINGES ARE ALLEGED AS DEFECTIVE. PHARMACIST PROVIDED PHONE NUMBER FOR THE CUSTOMER'S CAREGIVER. MANUFACTURER WAS UNABLE TO CONTACT CAREGIVER VIA TELEPHONE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 13546179 ↗
• MalfunctionJan 3, 2022Component Missing; Component Missing

  CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS 31G SYRINGES. CUSTOMER STATED THAT THE PLUNGER CAP WAS MISSING FROM THE SYRINGES. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THIS WAS THE FIRST TIME THE CUSTOMER IS USING THE PRODUCT OUT OF THIS PACKAGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13141411 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Improper Flow or Infusion; Fluid/Blood Leak; Improper Flow or Infusion

  CONSUMER REPORTED COMPLAINT FOR THE 31G TRUEPLUS SYRINGES. CUSTOMER STATED THAT WHEN SHE ATTEMPTED TO ADMINISTER HER INSULIN IT WOULD LEAK FROM THE SYRINGE. CUSTOMER STATED THAT THE INSULIN WOULD ALSO SOMETIMES COME OUT OF HER ARM. CUSTOMER STATED THIS WAS THE FIRST TIME SHE WAS USING THE PRODUCT OUT OF THE PACKAGE. THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. CUSTOMER IS USING COMPATIBLE PRODUCT AND THE PEN NEEDLE WAS PROPERLY ALIGNED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT CLAIM SHE WAS INJURED USING THE SYRINGES AND NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12408551 ↗
• MalfunctionDec 29, 2020Material Twisted/Bent; Material Twisted/Bent

  COMPLAINT RECEIVED VIA EMAIL. CONSUMER REPORTED COMPLAINT FOR SYRINGES. CUSTOMER SENT A LETTER STATING HIS WIFE PURCHASED INSULIN SYRINGE 31G AND NEEDLES ARE BENT. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11091569 ↗
• MalfunctionJul 8, 2020Filling Problem; Material Twisted/Bent; Filling Problem; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR SYRINGE NOT FULLY ASPIRATING AND SEVERAL NEEDLES BEING BENT. CUSTOMER STATED THAT THE SYRINGE IS PULLING AIR IN THE SYRINGE AND A FEW NEEDLES WERE BENT. CUSTOMER IS USING THE SYRINGE FOR HIS DOG. CUSTOMER DOES NOT CURRENTLY HAVE ANY OF THE SYRINGES THAT ARE WORKING PROPERLY. CUSTOMER STATES THAT HE DISCARDED THE SYRINGES THAT WERE BAD. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGES LOT MANUFACTURER¿S EXPIRATION DATE IS 05/28/2022 AND OPEN DATE IS 6 MONTHS AGO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10247644 ↗
• MalfunctionJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR POTENTIAL RISK ASSOCIATED WITH NEEDLE STICK. HUSBAND SENT EMAILING ON BEHALF OF THE CUSTOMER. CUSTOMER STATED THAT HIS WIFE WAS OPENING A NEW BAG OF SYRINGES. ONE OF THE SYRINGES DID NOT HAVE A CAP ON AND STUCK HER FINGER. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 04/16/2022 AND OPEN DATE IS UNDISCLOSED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10106785 ↗
• MalfunctionMay 13, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR SYRINGE BENDING WHEN INSERTING SYRINGE INTO INSULIN BOTTLE. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 11/18/2021 AND OPEN DATE IS APPROXIMATELY ONE MONTH AGO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051554 ↗
• MalfunctionApr 28, 2020Material Twisted/Bent; Material Twisted/Bent

  CONSUMER REPORTED COMPLAINT FOR BENDING OF SYRINGE UPON DRAWING OF INSULIN. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. CUSTOMER STATES THAT WHEN SHE REMOVES THE CAP FROM THE SYRINGE TO EXPOSE THE NEEDLE TO USE THE SYRINGE AND SHE ATTEMPTS TO DRAW THE INSULIN; THE NEEDLE WILL NOT PIERCE THE TOP PORTION OF THE INSULIN BOTTLE AND BENDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007697 ↗
• MalfunctionFeb 26, 2020Filling Problem; Filling Problem

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ ASPIRATION DUE TO BUBBLE FORMING IN SYRINGE. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 04/28/2022 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756335 ↗
• MalfunctionJan 6, 2020No Flow; No Flow

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF SYRINGES. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER WAS CONCERNED THAT THE SYRINGES WERE NOT DISPENSING HIS INSULIN CORRECTLY. PHARMACIST DID NOT STATE HOW LONG CUSTOMER HAS BEEN USING THE PRODUCT. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID NOT NEED MEDICAL INTERVENTION RELATED TO THE USE OF THE SYRINGES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554289 ↗
• MalfunctionNov 6, 2019Inaccurate Delivery; Inaccurate Delivery

  CONSUMER REPORTED COMPLAINT FOR INACCURATE DISPENSE/ASPIRATION OF SYRINGE. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE SYRINGE LOT MANUFACTURER¿S EXPIRATION DATE IS 03/13/2022 AND OPEN VIAL DATE IS 10/11/2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284232 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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
• 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-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