HydroPICC Catheter Kit Recalled for Missing Safety Warnings
Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events 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: FDA Class II medical device with missing critical safety warnings from the Instructions For Use. Although no adverse events have been reported, the missing warnings address significant risks (adult-use only and inadequate vessel sizing), qualifying this 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 Maximal Barrier Kits (Model Number 80002004, Lot Number 11469666) distributed in Illinois and Texas. A total of 58 units are affected by this recall.
The kits were provided with an incorrect revision of the Instructions For Use (IFU). The incorrect instructions do not include the following critical warnings: 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.
Healthcare providers and facilities that may have received these affected kits should be aware of the missing safety warnings. No adverse events have been reported to date in connection with this issue.
The recalled product
- Product
- HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Manufacturer
- Access Vascular, Inc
- Category
- Medical Device
- Hazard
- missing-warnings
- improper-sizing
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: 00850030354068
- Lot Number: 11469666
Distribution
Distributed nationwide across the United States.
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