HydroMID Basic Kit 80004002Recalls & reported problems

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.

2 other recalls cover devices cleared under the same FDA submission (K203069); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 16, 2022Open, Classified

   Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

   Z-1129-2023 · Root cause: Incorrect or no expiration date · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203069. One submission often covers many models, so check the product and lot details in each record.

• Z-1155-2023 · Dec 22, 2022 · Open, Classified
  HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 8000
• Z-1156-2023 · Dec 22, 2022 · Open, Classified
  HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004