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Kaiser Permanente Kit Pack

OASIS MEDICAL, INC. · Model KP-4711-SP, B-KP-4711-SP · UDI-DI 00845819006252

PZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 3 eaches of Anterior Chamber Cannula, 27g x 7/8", 4mm Bend (GTIN: 00845819001455) 1 eaches of Simcoe Cortex Cannula, 23g x 7/8”, Curved (GTIN: 00845819006061) 1 eaches of A/C Washout Cannula, 19g x 1", 8mm Bend, Flattened (GTIN: 00845819001592) 1 eaches of Hydrodissection Cannula, 25g x 7/8”, 8mm Bend (GTIN: 00845819001516)

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.