# FDA recall Z-0815-2020

> **Cook Inc.** · Class II · device recall initiated 2019-12-27.

## Product

Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

## Reason for recall

Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

## Distribution

Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom.

## Key facts

- **Recall number:** Z-0815-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-27
- **Report date:** 2020-01-22
- **Termination date:** 2020-11-23

- **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-0815-2020

## Citation

> AI Analytics. FDA recall Z-0815-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0815-2020. Source: US FDA. Licensed CC0.

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