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Low Profile Enteral Feeding Device Kit
FIDMI MEDICAL LTD · Model FG-20F- ORANGE · UDI-DI 07290018632017
10
510(k) clearances
1,228
Adverse events (18 deaths)
25
Recalls
24
Facilities
Description
The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-11 | Boston Scientific Corp | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices b |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2010-03-29 | Argon Medical Devices, Inc | There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| 2009-01-20 | C R Bard Inc | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
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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.