FDA Device Intelligence
HomeGrace Medical, Inc. › POPE VENT TUBE

POPE VENT TUBE

Grace Medical, Inc. · Model 525-643 · UDI-DI 00844505014366

ETD Prescription
1
510(k) clearances
92
Adverse events
14
Recalls
36
Facilities

Description

POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK

Recalls

DateFirmReason
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-24Adept Medical LtdLack of 510(k) clearance.
2024-11-19Olympus Corporation of the AmericasPotential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ven
2023-12-11Olympus Corporation of the AmericasThe expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.