# FDA recall Z-0331-2019

> **Cook Medical Incorporated** · Class II · device recall initiated 2018-09-25.

## Product

Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80      Product Usage:  The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

## Reason for recall

The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.

## Distribution

US Nationwide Distribution  in the states of:  AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.

## Key facts

- **Recall number:** Z-0331-2019
- **Recalling firm:** Cook Medical Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-25
- **Report date:** 2018-11-07
- **Termination date:** 2020-06-04

- **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-0331-2019

## Citation

> AI Analytics. FDA recall Z-0331-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0331-2019. Source: US FDA. Licensed CC0.

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