Arrow recalls Percutaneous Thrombolytic Device kits with PTD tip separation risk. Affected kits include specific lot numbers and components. Stop using if you have the recalled model.
The firm received reports indicating PTD tip separation during use.
Arrow is recalling Percutaneous Thrombolytic Device kits that may separate during use, potentially causing complications. This risk affects specific lot numbers and components.
The PTD tip can separate during use, which may cause blockages or complications in dialysis treatments. This separation risk is reported by Arrow but does not indicate immediate danger in normal use.
Healthcare professionals using the Arrow-Trerotola Over-The-Wire PTD Kit for dialysis treatments are most at risk. Patients with arterio-venous fistulae or synthetic grafts may be affected if the device separates during use.
Check for the product code 'PT-65709-WC' and specific lot numbers listed in the recall notice. The affected kits include components with lot numbers like 13C20C2082 or 14C20C1417.
Look for the lot number on the device or component packaging, such as 13C20C2082 for PT-65709-C.
If your kit matches the listed lot numbers, stop using it immediately to prevent potential separation during dialysis treatments.
The recall reports that the PTD tip can separate during use, which may cause blockages or complications in dialysis treatments.
Check the lot numbers on the components, such as 13C20C2082 for PT-65709-C or 14C20C1417 for PT-65709-HS, as listed in the recall notice.
The recall does not specify a return process, but you should stop using the device if it matches the affected lot numbers.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0626-2022 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0626-2022 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.