Important Safety Information: Foley Catheters, Drainage Bags and Urine Meters.
- Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
- For urological use only.
- Warning: On catheter, do not use ointments or lubricants having a petrolatum base. They will damage latex and may cause balloon to burst.
- Warning: After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
- Do not exceed recommended balloon capacities
- Aggressive traction, particularly in the presence of suturing is not recommended for 100% silicone catheters
- Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.
- Catheters should be replaced in accordance with the CDC guideline, "Guideline for Prevention of Catheter-Associated Urinary Tract Infection." At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.
- Do not resterilize.
- Sterile unless package is opened or damaged
Important Safety Information: StatLock Foley Stabilization Device
Indications for use: The StatLock® Device is a stabilization device for compatible catheters..
Contraindications: Known tape or adhesive allergies.
Warnings and Precautions:
1. Do not use the StatLock® device where loss of adherence could occur, such as with a confused patient, unattended access device, diaphoretic or nonadherent skin.
2. Observe universal blood and body fluid precautions and infection control procedures, during the StatLock device application and removal.
3. Minimize catheter manipulation during StatLock® stabilization device application and removal.
1. The StatLock® device should be assessed daily and changed when clinically indicated, at least every seven days.
2. If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide. Do not use alcohol or prepackaged bathing systems, which could lead to early lifting.
3. If showering/bathing, cover with plastic wrap or waterproof dressing.
4. Conduct skin assessment prior to application and repeat daily per facility protocol.
5. Use clinical judgement on the removal of the StatLock® stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity.
Sterile unless package is opened or damaged.