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
Reported: March 1, 2023 Initiated: December 22, 2022 #Z-1156-2023
Product Description
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
Reason for Recall
Label with the incorrect component listed on the inner kit Tyvek header bag
Details
- Recalling Firm
- Access Vascular, Inc
- Units Affected
- 445 units
- Distribution
- US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Access Vascular, Inc. Units affected: 445 units.
Why was this product recalled? ▼
Label with the incorrect component listed on the inner kit Tyvek header bag
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1156-2023.
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