Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Reported: January 19, 2022 Initiated: December 8, 2021 #Z-0465-2022
Product Description
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Reason for Recall
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Details
- Recalling Firm
- Technomed Europe
- Units Affected
- 117,672 devices
- Distribution
- US Nationwide distribution in the states of California, Florida, and Ohio.
- Location
- Maastricht-Airport, N/A
Frequently Asked Questions
What product was recalled? ▼
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.. Recalled by Technomed Europe. Units affected: 117,672 devices.
Why was this product recalled? ▼
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0465-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11