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Dilator Tube Set, Single Use, Sterile
KOROS U.S.A., INC. · Model 7332-99D · UDI-DI 10840199500007
10
510(k) clearances
329
Adverse events
21
Recalls
65
Facilities
Description
The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. It consists of the Following; 7332-73D, -74D, -75D, 76D, 86D, 89D
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.