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MICROTEK 1 (UDI 00748426002399)Recalls & reported problems

Microtek Medical LLC · BAG DECANTER II · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

  1. 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-2640-2024 · Root cause: Device Design · FDA record ↗

Other CONTAINER, I.V. devices

All CONTAINER, I.V. devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.