Technomed Europe: Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

Is my product affected?

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

• UPC 08718375861707
• UPC 08718375867549
• UPC 08718375865439
• UPC 08718375867853
• UPC 08718375861691
• UPC 08718375861684
• UPC 08718375861547
• UPC 08718375866863

Check against the official notice below — it lists the full affected range.

What happened

Technomed Europe is recalling approximately 117,672 disposable subdermal needle electrodes (corkscrew model) distributed nationwide in California, Florida, and Ohio. The recalled devices include model numbers TE/S50715-001-C, TE/S50725-001-C, and TE/S50715-001, along with several related lot numbers. The devices pose a safety hazard because the blue hub can detach from the corkscrew needle during use, potentially leaving the needle embedded in a patient's scalp.

The recall document does not specify a remedy or actions that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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: US Nationwide distribution in the states of California, Florida, and Ohio. Quantity: 117,672 devices Lot/code info: 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), 0

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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