# FDA recall Z-0633-2018

> **Cook Inc.** · Class II · device recall initiated 2017-07-31.

## Product

Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT    Product Usage:  The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

## Reason for recall

Central venous catheters may not fit over guide wire potentially causing procedure delay.

## Distribution

Worldwide distribution -  US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of  Belgium, India Italy, Spain, and United Kingdom.

## Key facts

- **Recall number:** Z-0633-2018
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-31
- **Report date:** 2018-02-21
- **Termination date:** 2019-05-08

- **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-0633-2018

## Citation

> AI Analytics. FDA recall Z-0633-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0633-2018. Source: US FDA. Licensed CC0.

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