Lower riskMedical device recall · FDA · Published August 31, 2020
Cook Pediatric Nephrostomy Stent Set Recall: Shorter Indwell Time Risk
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.
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Contact the company
📍Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
“Cook Pediatric Nephrostomy Stent Set Recall: Shorter Indwell Time Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64415-cook-pediatric-nephrostomy-stent-set-recall-shorter-indwell-time-risk. Based on FDA recall #Z-0106-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0106-2021%22&limit=1).
Cook Inc. recalled Pediatric Nephrostomy Stent Sets on Aug. 31, 2020, because the indwell time decreases from four months to four weeks, according to the FDA. The agency announced the Class II recall under number Z-0106-2021.
How to tell if you have it
Brand: Cook
Product: Pediatric Nephrostomy Stent Set
Reference Part Numbers: 080208-S6 and 080208-S7
Order Numbers: G15034 and G15035
Quantity: 380 units
The hazard
The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from four months to four weeks. The current Instructions for Use (IFU) are being updated and will be provided with orders placed following implementation.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Transseptal Needle Recall (Oct. 8, 2021). Additional recent recalls include Cook Melker Cricothyrotomy Catheter Set (March 5, 2026), Cook Medical Multipurpose Drainage Catheter Recall (March 5, 2026), and Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025).
How to tell if you have this one
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.
Brand
Cook
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-0105-2021
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock.; All lots
368
Z-0106-2021
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.; All lots
380
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the reference part numbers (080208-S6/S7) or order numbers (G15034/G15035) on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0106-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0106-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.