Arrow recalls PT-45509 PTD Sets with components PT-45509-S6 and PT-45509-T due to reported tip separation during use. Affected units have specific lot numbers.
The firm received reports indicating PTD tip separation during use.
Arrow is recalling certain Percutaneous Thrombolytic Device (PTD) sets that contain components PT-45509-S6 and PT-45509-T. The recall is due to reports of the PTD tip separating during use, which could lead to complications in medical procedures.
The device tip can separate during use, potentially causing complications in dialysis treatments. This separation may lead to issues with the medical procedure or equipment malfunction.
Patients using dialysis treatments with the Arrow PTD set are most at risk. The affected units have specific lot numbers and component codes.
Check for the product name 'Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509' with components PT-45509-S6 and PT-45509-T. Affected units have specific lot numbers listed in the recall details.
Identify the lot numbers and component codes listed in the recall notice to determine if your device is affected.
The recall reports that the PTD tip can separate during use, which may cause complications in dialysis treatments.
Check the lot numbers and component codes listed in the recall notice. Affected units have specific lot numbers like 13F20A0209, 13F20B0054, etc., with components PT-45509-S6 and PT-45509-T.
The recall does not specify a stop-use instruction; the hazard is reported but not severe enough to require immediate discontinuation.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0627-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0627-2022 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.
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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.
