# FDA recall Z-1845-2020

> **TeDan Surgical Innovations LLC** · Class II · device recall initiated 2019-07-16.

## Product

Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

## Reason for recall

There was incorrect raw material used in the production of the identified lot.

## Distribution

US Nationwide distribution in the states of NJ.

## Key facts

- **Recall number:** Z-1845-2020
- **Recalling firm:** TeDan Surgical Innovations LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-16
- **Report date:** 2020-05-13
- **Termination date:** 2021-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2020

## Citation

> AI Analytics. FDA recall Z-1845-2020. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1845-2020. Source: US FDA. Licensed CC0.

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