Bochum, N/A, Germany
INNOVATIVE TOMOGRAPHY PRODUCT GMBH recalls
1 recall recorded since 2018, most recently on 21 April 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 April 2021
- Reason
- Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2164-2021, Z-2162-2021, Z-2163-2021
- Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18
- 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.
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.