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Surgeon's Choice Card

OASIS MEDICAL, INC. · Model SCK 2004, B-SCK 2004 · UDI-DI 00845819006344

PZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Kit Packs Assembled from Non-Sterile Capped Product: 1 eaches of Olive Tip Capsule Polisher, 25g x 1”, Angled (GTIN: 00845819006337) 1 eaches of Cortex Extractor Cannula, Micro J-Shaped, 25g x 7/8” (GTIN: 00845819006351) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8” (0.4 x 22mm), 11mm Bend, Round End (GTIN: 00845819005958) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8” (GTIN: 00845819001479)

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.