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Kaiser Permanente Kit Pack

OASIS MEDICAL, INC. · Model KP-4706-SP, B-KP-4706-SP · UDI-DI 00845819006207

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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", 8mm Bend (GTIN: 00845819001448) 1 eaches of Subtenon Cannula, 19g x 1”, Flattened (GTIN: 00845819006054) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8" (GTIN: 00845819001479) 1 eaches of Terry Capsule Polisher, 27g x 7/8”, 6mm Bend (GTIN: 00845819004913) 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.