FDA Device recall Z-0105-2021
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508
- FDA Device
- Class II
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508 by Cook, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0105-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0105-2021%22
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