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: 80004004
FDA Recall Z-1155-2023 · Posted 2023-02-22
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Recalling FirmAccess Vascular, Inc
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2022-12-22
Product Quantity155 units
Reason for Recall
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Firm Action
Access Vascular issued letter to customers on 22 DEC 2022. Letter states reason for recall, health risk and action to take:
please refrain from using
these kits as additional kit components may be required may cause an inconvenient in
completing the procedure. AVI will provide a replacement label with the correct contents or
replace the product.
The following page identifies the shipments you have received with these impacted lots. Please forward
this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner. you have
any questions about this communication, please contact us at 781-538-6594.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of FL, TX, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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