CLASS II Device recall · Reported 21 Oct 2020 · FDA Enforcement Report
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference recalled
Cook is recalling Percutaneous Neonatal Pigtail Nephrostomy Set, Reference, distributed nationwide in the US. The recall was initiated on 31 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0105-2021
- FDA event ID
- 86411
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2020
- FDA classified
- 14 Oct 2020
- Reported
- 21 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 31 Aug 2020 | Recall initiated by company | |
| 14 Oct 2020 | Classified by FDA | +44 days |
| 21 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Is Percutaneous Neonatal Pigtail Nephrostomy Set, Reference recalled?
Yes. Cook recalled Percutaneous Neonatal Pigtail Nephrostomy Set, Reference on 31 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0105-2021.
Why was it 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.
Which lots are affected?
All lots
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cook
All 264| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Skinny Needle with Chiba Tip recalled by Cook | Cook | Other | Nationwide |
| Device | CLASS II | Flexor Check-Flo Introducer Ansel Modification recalled by Cook | Cook | Labeling Errors | 14 states |
| Device | CLASS II | Flexor Check-Flo Introducer Ansel Modification recalled by Cook | Cook | Labeling Errors | 14 states |
| Device | CLASS II | Transseptal Needle, Trocar recalled by Cook | Cook | Device Malfunction | Nationwide |
| Device | CLASS II | Transseptal Needle with Catheter recalled by Cook | Cook | Foreign Material | Nationwide |
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