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Forsure
FORSURE MEDICAL PRODUCTS LLC · Model 11100055 · UDI-DI 00815123011389
BTO
Prescription
1
510(k) clearances
6,618
Adverse events (163 deaths)
73
Recalls
74
Facilities
Description
A sterile hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | Covidien LLC | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-06-07 | Smiths Medical ASD Inc. | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
| 2024-05-29 | Smiths Medical ASD Inc. | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defec |
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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.