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Recall Observatory FDA recall evidence

Device product

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

Z-0465-2022

December 08, 2021

Class II

Product summary

Firm
Technomed Europe
Event
Event 89126
Status
Terminated
Classification
Class II
Quantity
117,672 devices
Official record key
device-enforcement:Z-0465-2022

Official wording

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.

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)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

Field note

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