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INTERMITTENT INJECTION SITE

SB-KAWASUMI LABORATORIES, INC. · Model INT-01 · UDI-DI 04987488104146

FOZ Prescription

510(k) clearances

49,694

Adverse events (141 deaths)

394

Recalls

198

Facilities

Description

The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be mated with any femail luer tapered lumen in a device, such as a catheter, communicating with blood or other body fluids. The port occludes the lumen of the catheter or other device. It also provides a latex septum for injection of fluids, including medication, or for aspiration of blood or fluids for testing, ETC. The septum is no-slitted. The Product is discarded when the main device is changed. This product comes with a luer protector cap which is removed and discarded before attaching the port to the catheter or device. This product is not specifically designed for use in hemodialysis systems.

Recalls

Date	Firm	Reason
2026-03-11	ARROW INTERNATIONAL, LLC	Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05	Cook Incorporated	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21	Becton Dickinson Infusion Therapy Systems, Inc.	Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

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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.