Arrow recalls specific Percutaneous Sheath Introducer Kits with unsealed packaging that may compromise sterility. Affected units include product codes ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1 with listed lot numbers. Contact Arrow for details.
Product sterility may be compromised due to unsealed packaging.
Arrow is recalling certain Percutaneous Sheath Introducer Kits because unsealed packaging could lead to contamination. This affects medical devices used during catheter procedures. If you have the listed product codes or lot numbers, you should check if your kit is affected.
Unsealed packaging could allow contaminants to enter the kit, potentially compromising sterility during medical procedures. This risk is specific to the packaging condition and not the device itself.
Healthcare professionals using the recalled kits for catheter procedures are most at risk. Patients receiving procedures with these kits may face potential contamination risks.
Check for product codes ASK-29803-SJH, ASK-29903-SJH, or ASK-29903-UW1 on the kit. Lot numbers listed in the recall include specific sequences like 13F17A0276 through 13F17M0197.
Identify the product code on the kit to see if it matches ASK-29803-SJH, ASK-29903-SJH, or ASK-29903-UW1.
Compare the lot number on the kit to the listed sequences to confirm if it is affected.
The recall addresses potential contamination risk from unsealed packaging, but the device itself is safe when properly packaged. Patients using the kit with a valid lot number are not at immediate risk.
The recall record does not specify a replacement process or remedy.
The recall does not require immediate discontinuation; affected kits should be checked for product code and lot number.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-1986-2018 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-1986-2018 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.
