# FDA recall Z-0105-2021

> **Cook Inc.** · Class II · device recall initiated 2020-08-31.

## 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 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.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-0105-2021
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-31
- **Report date:** 2020-10-21
- **Termination date:** 2021-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2021

## Citation

> AI Analytics. FDA recall Z-0105-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0105-2021. Source: US FDA. Licensed CC0.

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