HydroPICC 5Fr Dual Lumen recall
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Why was HydroPICC 5Fr Dual Lumen recalled?
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00850030354044; Lot Number: 11423187
- Product
- HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- Recalling firm
- Access Vascular, Inc
- Quantity
- 58 total
- Distribution
- US Nationwide distribution in the states of IL, TX.
- Recall date
- October 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)