# FDA recall Z-2162-2021

> **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. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm;   Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm);  Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm);  Article no. KIM 20/15, Length 150 mm, diameter	20 G (0.9 mm);  Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm);  Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm);   Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm);    Article no. KIM 18/15T, Length 150 mm,  diameter 18 G (1.25 mm);  Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm,   Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm);  Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm);  Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm);  Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm);  Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm);  A

## 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-2162-2021
- **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-2162-2021

## Citation

> AI Analytics. FDA recall Z-2162-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2162-2021. Source: US FDA. Licensed CC0.

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