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Technomed Europe

Technomed Engineering B.V. · Model TE/S48-637 · UDI-DI 08720791370237

GXZ IKT Prescription

510(k) clearances

329

Adverse events

Recalls

Facilities

Description

Disposable Subdermal Needle Electrode 14x0.38mm, Stainless Steel, 1.5m PVC parallel wire multi color 10 pairs

Recalls

Date	Firm	Reason
2021-12-08	Technomed Europe	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
2010-02-01	Stryker Instruments Div. of Stryker Corporation	Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.