# FDA recall Z-0588-2020

> **Cook Inc.** · Class I · device recall initiated 2019-11-08.

## Product

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575   For diagnostic and interventional vascular procedures.

## Reason for recall

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

## Distribution

Distribution to US states of  AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.

## Key facts

- **Recall number:** Z-0588-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-08
- **Report date:** 2019-12-18
- **Termination date:** 2021-02-01

- **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-0588-2020

## Citation

> AI Analytics. FDA recall Z-0588-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0588-2020. Source: US FDA. Licensed CC0.

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