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Rhythmlink®
RHYTHMLINK INTERNATIONAL, LLC · Model BNT110-STD-5462 · UDI-DI 00816312022575
GXZ
Prescription
10
510(k) clearances
329
Adverse events
21
Recalls
65
Facilities
Description
17 electrodes, 13mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector and 1 template, color-coded original BraiNet
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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Get your free API keyRead the docsData 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.