Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 368 |
| Distribution | Worldwide distribution - US Nationwide. |
| Initiated | 2020-08-31 |
| Classified | 2020-10-14 |
| Terminated | 2021-07-01 |
| Recall number | Z-0105-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-0105-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86411/
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