Cook recalls neonatal nephrostomy sets with shortened indwell time from 4 months to 4 weeks. Affected sets may cause complications if used longer than recommended.
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Cook is recalling neonatal nephrostomy sets that have a reduced safe usage period from 4 months to 4 weeks. This shorter time frame increases the risk of complications if the set is used beyond the recommended duration.
The set is designed to stay in place for 4 months, but the recall shows it can only safely stay for 4 weeks. Using it longer than this increases the risk of infection, blockage, or other complications in newborns.
Newborns requiring nephrostomy procedures and healthcare providers who use these sets. The risk is highest for infants with medical conditions that require long-term catheter use.
Check for the reference part number 080106 and order number G14508 on the product packaging. These sets were sold to hospitals and clinics for neonatal care.
Verify the reference part number 080106 and order number G14508 on the packaging to confirm if the set is affected.
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set has been reduced from 4 months to 4 weeks to address safety concerns.
Check the product packaging for reference part number 080106 and order number G14508. If affected, contact Cook for guidance on next steps.
The current instructions for use are being updated and will be provided with future orders.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0105-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0105-2021 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.
