Home / Recalls / Technomed Europe / Z-0465-2022

Z-0465-2022 Class II Terminated

Recalled by Technomed Europe — Maastricht-Airport, N/A

Recall Details

Product Type: Devices
Report Date: January 19, 2022
Initiation Date: December 8, 2021
Termination Date: May 31, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 117,672 devices

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.

Distribution Pattern

US Nationwide distribution in the states of California, Florida, and Ohio.

Code Information

Read as "Lot Number (UDI-DI, Product Number)": 048565 (08718375861707, TE/S50715-004), 048670 (08718375867549, TE/S50715-001-C), 048949 (08718375867549, TE/S50715-001-C), 049013 (08718375865439, SO-ELCS20), 049013 (08718375865439, SO-ELCS20), 049014 (08718375867549, TE/S50715-001-C), 049014 (08718375867549, TE/S50715-001-C), 049165 (08718375865439, SO-ELCS20), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049166 (08718375867853, TE/S50725-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049167 (08718375867549, TE/S50715-001-C), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049188 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049189 (08718375861707, TE/S50715-004), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049190 (08718375861691, TE/S50715-003), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049191 (08718375861684, TE/S50715-002), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049192 (08718375861547, TE/S50715-001), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049193 (08718375866863, TE/S50725-002), 049328 (08718375861707, TE/S50715-004), 049328 (08718375861707, TE/S50715-004), 049328 (08718375861707, TE/S50715-004), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049343 (08718375861691, TE/S50715-003), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049429 (08718375861547, TE/S50715-001), 049443 (08718375867549, TE/S50715-001-C), 049443 (08718375867549, TE/S50715-001-C), 049502 (08718375867549, TE/S50715-001-C), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049528 (08718375861547, TE/S50715-001), 049549 (08718375867549, TE/S50715-001-C), 049552 (08718375867549, TE/S50715-001-C), 049552 (08718375867549, TE/S50715-001-C), 049603 (08718375861691, TE/S50715-003), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049662 (08718375861547, TE/S50715-001), 049710 (08718375867549, TE/S50715-001-C), 049710 (08718375867549, TE/S50715-001-C), 049735 (08718375861707, TE/S50715-004), 049735 (08718375861707, TE/S50715-004), 049736 (08718375867549, TE/S50715-001-C), 049802 (08718375867549, TE/S50715-001-C), 049847 (08718375865439, SO-ELCS20), 049847 (08718375865439, SO-ELCS20), 049855 (08718375861691, TE/S50715-003), 049855 (08718375861691, TE/S50715-003), 049855 (08718375861691, TE/S50715-003), 049858 (08718375861707, TE/S50715-004), 049858 (08718375861707, TE/S50715-004), 049861 (08718375867549, TE/S50715-001-C), 049871 (08718375866863, TE/S50725-002), 049878 (08718375867549, TE/S50715-001-C), 049924 (08718375861707, TE/S50715-004), 049925 (08718375861684, TE/S50715-002), 049925 (08718375861684, TE/S50715-002), 049932 (08718375861707, TE/S50715-004), 049932 (08718375861707, TE/S50715-004), 049932 (08718375861707, TE/S50715-004), 049955 (08718375866863, TE/S50725-002), 049955 (08718375866863, TE/S50725-002), 049969 (08718375867549, TE/S50715-001-C), 049970 (08718375867549, TE/S50715-001-C), 049982 (08718375861547, TE/S50715-001), 049982 (08718375861547, TE/S50715-001), 049989 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 049990 (08718375861547, TE/S50715-001), 050077 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050106 (08718375861547, TE/S50715-001), 050136 (08718375867549, TE/S50715-001-C), 050136 (08718375867549, TE/S50715-001-C), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050240 (08718375861707, TE/S50715-004), 050395 (08718375866863, TE/S50725-002), 050395 (08718375866863, TE/S50725-002), 050715 (N/A, NS/DC990106.041-001)