HydroMID Peripheral Access Kit Recalled for Mislabeled Packaging
Access Vascular is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit because the outer bag and inner Tyvek header bag are mislabeled. The device is used for short-term peripheral venous access.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall for a risk-of-harm medical device (peripheral venous access kit) with labeling errors. Although no illnesses or injuries have been reported, mislabeling on medical device instructions poses a potential for improper use and patient harm.
Plain-English summary
Access Vascular, Inc. is recalling the HydroMID 4Fr Single Lumen Maximal Barrier Kit (Model 80004004), a medical device intended for short-term peripheral venous access during intravenous therapy. The recall affects 155 units that were distributed nationwide in Florida, Texas, and Washington.
The device has been mislabeled on the outer bag and inner kit Tyvek header bag.
Mislabeling on medical device packaging can compromise proper use and patient safety.
Consumers and healthcare providers who received affected units should contact Access Vascular, Inc. for further guidance.
The recalled product
- Product
- 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
- Manufacturer
- Access Vascular, Inc
- Hazard
- Affected units
- 155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00850030354020 Lot Number: 11434018
Distribution
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