Reported Oct 21, 2020 · Terminated
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
080106 | Percutaneous Neonatal Pigtail Nephrostomy Set, Reference , 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. |
- Lot codes and dates
- All lots
- Amount recalled
- 368
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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