Access Vascular recalls HydroPICC 5Fr Dual Lumen kits with incorrect instructions that omit adult use warnings. This could risk harm if used in inadequately sized vessels. No injuries reported.
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.
Access Vascular is recalling HydroPICC 5Fr Dual Lumen kits with a specific model number because they came with incorrect instructions that don't warn the device is for adult use only. Using these kits in inadequately sized vessels could cause health risks, though no injuries have been reported.
The kits include instructions that don't state the HydroPICC Dual Lumen Catheter is for adult use only. If used in inadequately sized vessels, this could cause health risks. No injuries have been reported to date.
Healthcare professionals using the HydroPICC kits with model number 80002002 are likely affected. Patients receiving care with these kits may be at risk if the catheter is used in vessels that are too small.
Check for the model number 80002002 on the HydroPICC kit. The lot number 11423187 is associated with this specific recall.
Verify the kit includes the correct Instructions For Use that state the HydroPICC Dual Lumen Catheter is for adult use only.
The recall involves kits with incorrect instructions that omit adult use warnings. Using these kits in inadequately sized vessels could cause health risks, but no injuries have been reported.
The affected model number is 80002002.
Look for the model number 80002002 and lot number 11423187 on the kit.
We’ve drafted a message you can send Access Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0114-2024 — Access Vascular Access Vascular Hello, I own a Access Vascular that is covered by recall Z-0114-2024 from Access Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
