# FDA recall Z-1483-2020

> **Deroyal Industries, Inc. Lafollette** · Class II · device recall initiated 2020-02-06.

## Product

Teleflex Pilling Aortic Punch, 4.0mm.  Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.

## Reason for recall

The sterile packaging has the potential to be compromised.

## Distribution

International distribution of Kuwait City, Kuwait.

## Key facts

- **Recall number:** Z-1483-2020
- **Recalling firm:** Deroyal Industries, Inc. Lafollette
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-06
- **Report date:** 2020-03-25
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Follette, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2020

## Citation

> AI Analytics. FDA recall Z-1483-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1483-2020. Source: US FDA. Licensed CC0.

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