Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kit (model 80002004) due to missing adult use warning in instructions, potentially risking use 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 Maximal Barrier Kits with model number 80002004 because the instructions don't warn that these catheters are for adult use only. Using them in smaller vessels could cause health risks, though no injuries have been reported yet.
The kit's instructions don't state that the catheter is only for adult use. If used in a vessel that's too small for an adult, it could cause health problems. No injuries have been reported so far.
Patients using this specific HydroPICC kit for vascular access are affected. Healthcare providers who use the kit for adult patients are most at risk if they don't follow the correct instructions.
Check for the model number 80002004 on the kit. The lot number 11469666 is also associated with this specific recall.
Verify the kit's instructions include the warning that the HydroPICC Dual Lumen Catheter is for adult use only.
The recall is for a potential risk if the catheter is used in an inadequately sized vessel, but no injuries have been reported.
Look for the model number 80002004 and lot number 11469666 on the kit.
The recall doesn't require stopping use immediately; check the instructions for the adult use warning.
We’ve drafted a message you can send Access Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0115-2024 — Access Vascular Access Vascular Hello, I own a Access Vascular that is covered by recall Z-0115-2024 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.
