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COOK INCORPORATED · Model G06425 · UDI-DI 00827002064256

KRA Prescription

510(k) clearances

9,137

Adverse events (366 deaths)

137

Recalls

150

Facilities

Description

Multi-Sideport Catheter Infusion Set Dual Check Valve

Recalls

Date	Firm	Reason
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge
2026-09-16	Boston Scientific Cork, Ltd.	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge

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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.