Cook recalls pediatric nephrostomy stent sets with reference part numbers 080208-S6/S7 and order numbers G15034/G15035 due to reduced indwell time from 4 months to 4 weeks. The current instructions for use are being updated.
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 pediatric nephrostomy stent sets that have a shorter intended use period (4 weeks instead of 4 months). This means the devices may need to be replaced more frequently to prevent complications.
The stent sets are designed to stay in place for 4 months, but the recall indicates they may only stay in place for 4 weeks. This shorter time could lead to complications if the device is not replaced on schedule.
Parents or caregivers of infants who use these stent sets for medical procedures. Infants with specific kidney conditions requiring this treatment are most at risk.
Check for reference part numbers 080208-S6 or 080208-S7 and order numbers G15034 or G15035. These products were sold to hospitals and clinics for pediatric patients.
Identify the reference part numbers (080208-S6/S7) or order numbers (G15034/G15035) on the device packaging.
The recall indicates the intended indwell time has been reduced from 4 months to 4 weeks, which may require more frequent replacements to prevent complications.
The manufacturer is updating the instructions for use and will provide the new instructions with future orders.
Check for reference part numbers 080208-S6 or 080208-S7 and order numbers G15034 or G15035 on the device packaging.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0106-2021 — Cook Cook Hello, I own a Cook that is covered by recall Z-0106-2021 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.
