CLT-15-MG

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>Polysorb™ sutures are indicated for use during surgical interventions, including ophthalmic surgery, for the purpose of soft tissue approximation and ligation, where use of an absorbable suture is appropriate. The intended purpose of the suture is soft tissue approximation or ligation.</p> <h3>Warnings</h3> <ul> <li>This device is provided sterile for single-use only. Do not reuse, reprocess or resterilize this device. Reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent impairment or life-threatening injury. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the sterile barrier system and packaging before use. Discard open, unused sutures in accordance with end user’s sharps containment, handling, and disposal procedures. Store at room temperature.</li> <li>Before employing Polysorb™ sutures for wound closure, healthcare professionals should consider the characteristics of the wound and absorption profile of the suture as the risk of wound dehiscence may vary with the site of application and the suture material used.</li> <li>As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice must be followed with respect to drainage and closure of contaminated or infected wounds.</li> <li>The use of this suture may be inappropriate in patients with any conditions which, in the opinion of the surgeon, may cause or contribute to delayed wound healing. </li> <li>As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in closure of the abdomen, chest, joints or other sites subject to expansion or requiring additional support.</li> <li>In surgery of the urinary or biliary tracts, care should be taken to avoid prolonged contact of this, or any other, suture with salt solutions, as calculus formation may result.</li> <li>Suture failure may result in bleeding, wound dehiscence, infection or vision loss (when used in ophthalmic procedures).</li> <li>Verify proper needle selection for application when performing ophthalmic procedures. Use of the incorrect needle may cause damage resulting in vision loss.</li> <li> This device contains nickel that may cause allergic reaction.</li> </ul>

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