Reported Jan 19, 2022 · Terminated
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C,…
Technomed Europe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Technomed Europe · Amerikalaan 71 · Maastricht-Airport, N/A · N/A
Is this the product you have?
- Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
- Lot codes and dates
263 of 263 codes
Read as "Lot Number (UDI-DIProduct Number)": 048565 (08718375861707TE/S50715-004)048670 (08718375867549TE/S50715-001-C)048949 (08718375867549TE/S50715-001-C)049013 (08718375865439SO-ELCS20)049013 (08718375865439SO-ELCS20)049014 (08718375867549TE/S50715-001-C)049014 (08718375867549TE/S50715-001-C)049165 (08718375865439SO-ELCS20)049166 (08718375867853TE/S50725-001-C)049166 (08718375867853TE/S50725-001-C)049166 (08718375867853TE/S50725-001-C)049166 (08718375867853TE/S50725-001-C)049167 (08718375867549TE/S50715-001-C)049167 (08718375867549TE/S50715-001-C)049167 (08718375867549TE/S50715-001-C)049167 (08718375867549TE/S50715-001-C)049188 (08718375861707TE/S50715-004)049188 (08718375861707TE/S50715-004)049188 (08718375861707TE/S50715-004)049188 (08718375861707TE/S50715-004)049188 (08718375861707TE/S50715-004)049188 (08718375861707TE/S50715-004)049189 (08718375861707TE/S50715-004)049189 (08718375861707TE/S50715-004)049189 (08718375861707TE/S50715-004)049189 (08718375861707TE/S50715-004)049189 (08718375861707TE/S50715-004)049190 (08718375861691TE/S50715-003)049190 (08718375861691TE/S50715-003)049190 (08718375861691
- Amount recalled
- 117,672 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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