[Recalled] 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); A
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 n |
|---|---|
| Brand / manufacturer | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2162-2021 |
| Country of notice | Germany |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 April 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
This Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.