Cook recalls Percutaneous Malecot Nephrostomy Sets with specific product numbers due to risk of stiff wire guide tip entering patients during use.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Cook is recalling certain Percutaneous Malecot Nephrostomy Sets because the wire guide might be loaded incorrectly, potentially causing the stiff tip to enter the patient instead of the flexible tip. This could lead to complications during medical procedures.
The wire guide may be incorrectly loaded into the wire guide holder, causing the stiff tip to enter the patient instead of the flexible tip. This could lead to complications during medical procedures if the wire guide is not properly positioned.
Patients undergoing medical procedures who use the recalled Percutaneous Malecot Nephrostomy Sets are most at risk. Healthcare providers using these sets for medical procedures may also be affected.
Check for product numbers G16714, G19107, G19108, NS8070854, 8078209, or 8116743 on the packaging or label. The product is sold globally and used in medical procedures.
Look for product numbers G16714, G19107, G19108, NS8070854, 8078209, or 8116743 on the packaging or label.
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip being introduced into the patient instead of the flexible tip, which could cause complications during medical procedures.
Check for product numbers G16714, G19107, G19108, NS8070854, 8078209, or 8116743 on the packaging or label.
The recall does not specify a remedy, so contact Cook Inc. directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0968-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-0968-2020 from Cook. 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.
