HydroPICC Catheter Kit Recall: Missing Critical Use-Restriction Warnings
Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.
What this means for you
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: The recall involves missing critical safety warnings in medical device instructions (adult-use-only and vessel-sizing restrictions). Although no adverse events have been reported, the omissions represent a risk-of-harm scenario. Per the rubric, recalls with theoretical risk and no reported injuries score at most 3, and this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Access Vascular, Inc. is recalling HydroPICC 5Fr Dual Lumen, 80cm guidewire catheter kits that were distributed with an incorrect revision of the Instructions For Use (IFU). The provided instructions are missing two critical safety warnings.
The missing warnings state that the HydroPICC Dual Lumen Catheter is for adult use only and that there is a potential risk to health if the catheter is used in an inadequately sized vessel. These omissions could result in the device being used inappropriately in pediatric patients or in vessels not suitable for the catheter's size.
The FDA classifies this as a Class II recall. As of the recall notice, there have been no reported adverse events associated with this issue. Patients or healthcare providers who have received affected units should consult the corrected Instructions For Use or contact Access Vascular, Inc. for proper guidance on appropriate use of this medical device.
The recalled product
- Product
- HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- Manufacturer
- Access Vascular, Inc
- Hazard
- mis-labeling
- pediatric-use-risk
- vessel-sizing-risk
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 (2)
- UDI-DI: 00850030354044
- Lot Number: 11423187
Distribution
Distributed nationwide across the United States.
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