Home › SB-KAWASUMI LABORATORIES, INC. › K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

SB-KAWASUMI LABORATORIES, INC. · Model PP01X00 · UDI-DI 04987488111342

PTI Prescription

510(k) clearances

162

Adverse events

Recalls

Facilities

Description

This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems. The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

Recalls

Date	Firm	Reason
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure
2020-06-19	Becton Dickinson & Company	Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure

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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.