Arrow recalls 5 Fr. X 65 cm Arrow-Trerotola PTD Kit (REF PT-65509-HFC) due to reported tip separation during use. Affected units include specific lot numbers and component codes.
The firm received reports indicating PTD tip separation during use.
Arrow is recalling certain Percutaneous Thrombolytic Device kits that may separate at the tip during use. This could cause complications for patients receiving dialysis treatments.
The recall reports that the PTD tip can separate during use, which may lead to complications in dialysis treatments. This separation could cause blockages or damage to the patient's vascular access.
Patients using hemodialysis treatments with the recalled Arrow-Trerotola PTD kits are most at risk. Healthcare providers who use these kits for dialysis access procedures should check if their equipment is affected.
Check for the product name 'Arrow-Trerotola Percutaneous Thrombolytic Device' with reference code PT-65509-HFC. Look for specific lot numbers listed in the recall notice.
Identify the lot number and component codes on your device to see if it matches the recalled units.
Reach out to Arrow Medical for guidance on whether your device is affected and next steps.
The recall reports tip separation during use, but the device is not inherently dangerous if used properly. Affected units have a reported risk of separation.
Check the lot number and component codes on your device against the specific numbers listed in the recall notice.
No, but you should check if your device is affected and contact Arrow Medical for guidance.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0628-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0628-2022 from Arrow. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
