# FDA recall Z-0506-2020

> **Cook Inc.** · Class II · device recall initiated 2019-09-17.

## Product

Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.

## Reason for recall

Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.

## Distribution

US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.

## Key facts

- **Recall number:** Z-0506-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-17
- **Report date:** 2019-11-27
- **Termination date:** 2020-05-21

- **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-0506-2020

## Citation

> AI Analytics. FDA recall Z-0506-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0506-2020. Source: US FDA. Licensed CC0.

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