Class II Recall

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

Summary

The FDA issued a Class II for Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Num by Technomed Europe. Reason: 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

Source

Device Recall

External ID

Z-0465-2022

Action Date

2022-01-19

Status

Terminated

Product Description

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

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), 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)

Quantity Affected: 117,672 devices

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-12-08

Company

Technomed Europe

Maastricht-Airport, N/A

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 106 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Technomed Europe has 6 FDA actions in our database, including 3 recalls and 3 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Technomed Europe) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Technomed Europe have FDA actions?

Technomed Europe has 6 FDA actions in our database, including 3 recalls and 3 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0465-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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