Device Recall Bur Hypo Pack

Lots: 1010.0, 1102.1, and 1103.1

General and Plastic Surgery Devices

2

Yes

Wordwide Distribution - USA including IL, AZ, PA, CT, MO, WI, NY, TX, OR, ME, FL, VA, and MS and the countries of Mexico and Qatar.

The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. || Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. || 2. 60cm x 85 cm Steri Drape || 3. Drain with Connector || 4. 4 x Gauze Rolls || Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. || Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.