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Surgeon's Choice Card

OASIS MEDICAL, INC. · Model SCK 2009, B-SCK 2009 · UDI-DI 00845819002971

PZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:00845819001448) 1 eaches Hydrodissection Cannula, 27g x 3/4'', 1mm Bend(GTIN:00845819001530) 1 eaches Irrigating Cystotome, 25g x 5/8", Reverse Formed (GTIN:00845819000977)

Recalls

Date	Firm	Reason
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility
2021-11-17	Beaver Visitec International, Inc.	Kit packaging may have small holes compromising product sterility

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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.