[Recalled] Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. — There is a high risk of the blue hub detaching from the corkscrew needle, resul… | FDA 202
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. |
|---|---|
| Brand / manufacturer | Technomed Europe |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0465-2022 |
| Country of notice | Netherlands |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 December 2021 |
| EAN / barcode | 08718375861707 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
This Class II recall concerns device products distributed in Netherlands 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 →
Related recalls from Technomed Europe
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.