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PILLING
TELEFLEX INCORPORATED · Model IPN008299 · UDI-DI 34026704204916
BTO
Prescription
10
510(k) clearances
6,588
Adverse events (163 deaths)
73
Recalls
75
Facilities
Description
CLJ TRACHEA TUBE IMP #5 FENNESTRATED SS
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.