# FDA recall Z-2163-2021

> **INNOVATIVE TOMOGRAPHY PRODUCT GMBH** · Class II · device recall initiated 2021-04-21.

## Product

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:     Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm);  Article no. KIR 23/05N, Length 50 mm, Diameter	23 G (0.6 mm);   Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm);  Article no. KIR 23/07N, Length 70 mm, Diameter	23 G (0.6 mm);  Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm);  Article no. KIR 23/15, Length 150 mm, Diameter	23 G (0.6 mm);  Article no. KIR 21/10, Length 100 mm, Diameter	21 G (0.8 mm);  Article no. KIR 21/12, Length 120 mm, Diameter	21 G (0.8 mm);  Article no. KIR 21/15, Length 150 mm, Diameter	21 G (0.8 mm);  Article no. KIR 21/20, Length 200 mm, Diameter	21 G (0.8 mm);  Article no. KIR 17/15, Length 150 mm, Diameter	17 G (1.40mm)  Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm)      *NOT DISTRIBUTED WITHIN THE US

## Reason for recall

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-2163-2021
- **Recalling firm:** INNOVATIVE TOMOGRAPHY PRODUCT GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-21
- **Report date:** 2021-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bochum, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2021

## Citation

> AI Analytics. FDA recall Z-2163-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2163-2021. Source: US FDA. Licensed CC0.

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