Indication for use
Surgiphor Sterile Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
Surgiphor Sterile Wound Irrigation System should not be used in patients with known allergic reaction to any of the ingredients in the solutions.
Surgiphor Sterile Wound Irrigation System should also not be combined with other irrigation or antiseptic solutions due to potential reactions and reduction in the effectiveness of the system. Not for use in neonates. Warnings: Do not use or mix with other cleansers, soaps, lotions, or ointments. Do not use for injection or infusion.
Do not swallow. Do not use in eyes or ear canals. Discontinue use immediately if irritation or an allergic reaction occurs. Do not use if packaging is damaged or if seal integrity is compromised. Do not reuse Surgiphor™ solution after 24 hours.
Surgiphor solution may cause a temporary irritation and/or burning sensation on exposed skin in very rare cases.
Surgiphor solution may cause allergic reactions such as rash or skin irritation in patients with iodine allergy.
Anaphylaxis with the use of Surgiphor solution may occur in patients with severe iodine allergy. Federal law restricts this device to sale by or on the order of a licensed physician.
Single patient use only. Not for at-home use.
* (ATCC #10231), (ATCC #9027), (ATCC #16404), (ATCC #8739), (ATCC #6538).
^ PVP-I is a preservative in the solution and is not intended to be used as an antimicrobial.
- Data on file: REF-20098 SURGIPHOR – Solution Preservative Effectiveness Report
- Data on file: REF-20100 SURGIPHOR Gamma Sterilization Validation Test Report