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Medicon
Medicon eG. Chirurgiemechaniker-Genossenschaft · Model 01.27.17 · UDI-DI 04046826000196
GDZ
Prescription
10
510(k) clearances
128
Adverse events
13
Recalls
445
Facilities
Description
scalpel hdl no 7K 12cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2022-09-02 | Steris Corporation | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's |
| 2016-03-11 | Integra York PA, Inc | One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle. |
| 2014-09-26 | Teleflex Medical | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. |
| 2014-06-24 | Bard Access Systems | Potential for inadvertent scalpel stick injury involving the safety scalpel. |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the ster |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the ster |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the ster |
| 2013-11-12 | Ansell Sandel Medical Industries LLC | Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the ster |
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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.