# FDA recall Z-1381-2019

> **Dornier Medtech America, Inc.** · Class II · device recall initiated 2019-04-01.

## Product

Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers  Part Number/Description:  K1001291 600 micron single use fiber  K2011824 600 micron single use fiber  K1001293 600 micron single use fiber  K2011826 600 micron 5X reusable fiber  K1008084 600 micron single use fiber  K2011828 400 micron 5X reusable fiber  K1010500 600 micron fibertome fiber  K2012021 600 micron single use fiber  K1015640 AngioSpot Fiber Kit  K2012393 600 micron single use fiber  K2010292 400 micron single use fiber  K2012439 600 micron 5X reusable fiber  K2010667  micron ITT fiber  K2012875 600 micron 3X reusable fiber  K2010710 400 micron single use fiber  K2012879 400 micron 3X reusable fiber  K2011822 400 micron single use fiber  Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D Magna

## Reason for recall

Pin hole package failures compromising sterility of product

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1381-2019
- **Recalling firm:** Dornier Medtech America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-01
- **Report date:** 2019-05-29
- **Termination date:** 2020-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kennesaw, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2019

## Citation

> AI Analytics. FDA recall Z-1381-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1381-2019. Source: US FDA. Licensed CC0.

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