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Dover

Cardinal Health 200, LLC · Model 6070 · UDI-DI 10192253028065

PPG Prescription
0
510(k) clearances
8
Adverse events
1
Recalls
11
Facilities

Description

100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT

Recalls

DateFirmReason
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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

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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.