MICROTEK 1 (UDI 00748426002085)Recalls & reported problems
Microtek Medical LLC · C-FLO BAG DECANTER · 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 00748426002085), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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-2639-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Defective Component1
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.
MalfunctionJul 15, 2021Defective Component; Defective Component
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING DIFFICULTY INSERTING THE 2000S SPIKES INTO BAGS OF HEPARIN 2000 UNITS IN SALINE 100 ML. IT WAS REQUIRING FORCE TO INSERT THE DECANTER INTO THE PORT ON THE SALINE BAGS AND THEY WERE USING A TWISTING MOTION THAT WAS CAUSING PLASTIC SHAVINGS TO RELEASE FROM THE BAG PORT THAT COULD POTENTIALLY FALL INTO THE SALINE SOLUTION. NO ADVERSE PATIENT REACTIONS AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12173960 ↗
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- SECURE® 66040Metrix Company, The · Container, I.V.1 recall8 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.