MICROTEK 1 (UDI 00748426002535)Recalls & reported problems
Microtek Medical LLC · TRANSFER DEVICE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426002535), received between May 20, 2022 and May 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Microbial Contamination of Device” (1 report).
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-2643-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE DECANTER TRANSFER DEVICE HAS BROWN CONTAMINANTS ON THE SPIKE, PRIOR TO INSERTING THE DEVICE IN THE MEDICATION VIAL. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14462474 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.