MICROTEK 1 (UDI 00748426002511)Recalls & reported problems
Microtek Medical LLC · VIAL DECANTER · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00748426002511), received between Jun 7, 2019 and Dec 10, 2020 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 3, 2024Open, Classified
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Z-2642-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Component Misassembled3
- Contamination /Decontamination Problem2
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Device Slipped1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2020Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE VIAL DECANTER SPIKE CAP CAME OFF IN THE PACKAGING WHICH COMPROMISED THE USERS' ABILITY TO ASEPTICALLY DECANT IV FLUIDS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10983457 ↗MalfunctionDec 10, 2020Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE VIAL DECANTER SPIKE CAP CAME OFF IN THE PACKAGING WHICH COMPROMISED THE USERS' ABILITY TO ASEPTICALLY DECANT IV FLUIDS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10983456 ↗MalfunctionDec 10, 2020Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE VIAL DECANTER SPIKE CAP CAME OFF IN THE PACKAGING WHICH COMPROMISED THE USERS' ABILITY TO ASEPTICALLY DECANT IV FLUIDS. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10983446 ↗MalfunctionNov 6, 2020Delivered as Unsterile Product
THE CAP COVERING THE SPIKE OF THE MICROTEK MEDICAL INC. MEDI-PLAST VIAL DECANTERS COMES OFF IN THE PACKAGING. UNABLE TO USE THE VIAL DECANTER ASEPTICALLY BECAUSE THE SPIKE IS COMPROMISED WITH THE COVER OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10800444 ↗MalfunctionNov 5, 2020Device Slipped; Detachment of Device or Device Component
MEDI-PLAST VIAL DECANTER FROM MICROTEK MEDICAL, INC. HAS ISSUES WITH THE VIAL DECANTER CAP NOT STAYING ON THE DECANTER SPIKE WHILE IN THE PACKAGE. THIS PROBLEM PREVENTS THE ASEPTIC DECANTING FROM GLASS VIALS. THE CAP FROM THIS PARTICULAR SUPPLY WAS NOT COVERING THE SPIKE (REF #2006S, LOT #200318).
Patient problems: Insufficient Information
MAUDE report 10791884 ↗MalfunctionSep 28, 2020Material Separation
MICROTEK VIAL DECANTERS HAVE A CAP ON THE SPIKE THAT IS INSERTED INTO THE GLASS VIAL. THE CAP OFTEN COMES OFF THE SPIKE WHILE IN THE PACKAGE THEREFORE COMPROMISING THE ABILITY TO ASEPTICALLY DECANT IV FLUIDS FROM GLASS VIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10592614 ↗MalfunctionAug 6, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT SHAVINGS WERE OBSERVED UNDERNEATH THE CAP ON THE POINTED END OF THE DECANTER. IT WAS NOTED THAT THREE DECANTERS HAD THIS ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8865223 ↗MalfunctionJun 7, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT SHAVINGS WERE OBSERVED UNDERNEATH THE CAP ON THE POINTED END OF THE DECANTER. IT WAS NOTED THAT THREE DECANTERS HAD THIS ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8680297 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.