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Prescriptive Information

PRESCRIPTIVE INFORMATION FOR FOLEY CATHETERS, DRAINAGE BAGS AND URINE METERS


INDICATIONS FOR USE:
  For urological use only.
 
CAUTIONS
  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
  • Do not aspirate urine through drainage funnel wall.
WARNINGS
  • On catheter, do not use ointments or lubricants having a petrolatum base. They will damage latex and may cause balloon to burst.
  • 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.  
ADDITIONAL INFORMATION
  • 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. 
  • Do not exceed recommended balloon capacities.
  • Single patient use, do not reuse.
  • Sterile unless package is opened or damaged.
  • Do not resterilize.
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.  


STATLOCK® FOLEY STABILIZATION DEVICES

INDICATIONS FOR USE: The STATLOCK® Stabilization Device is used with compatible catheters.  

CONTRAINDICATIONS: Known tape or adhesive allergies.  

WARNINGS AND PRECAUTIONS

  • Do not use the STATLOCK® stabilization device where loss of adherence could occur, such as with a confused patient, unattended access device, diaphoretic or nonadherent skin.
  • Observe universal blood and body fluid precautions and infection control procedures, during the STATLOCK® stabilization device application and removal.
  • Minimize catheter manipulation during STATLOCK® stabilization device application and removal.  
DAILY MAINTENANCE
  • The STATLOCK® stabilization device should be assessed daily and changed when clinically indicated, at least every seven days. 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. If showering/bathing, cover with plastic wrap or waterproof dressing.
  • Conduct skin assessment prior to application and repeat daily per facility protocol. 
  • Use clinical judgment 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.  


For the latest information, always check the “Instructions for Use” that comes packaged with the product.  

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