Class 2 Device Recall Bur Hypo Pack

• Date Initiated by Firm: June 22, 2011
• Date Posted: January 27, 2012
• Recall Status: Terminated on August 28, 2012
• Recall Number: Z-0920-2012
• Recall Event ID: 60844
• 510(K)Number: K093166
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: 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.
• Code Information: Lots: 1010.0, 1102.1, and 1103.1
• Recalling Firm/ Manufacturer: Novomedicus Llc; 990 Gulf Winds Way; Nokomis FL 34275-3363
• For Additional Information Contact: 941-7579101
• Manufacturer Reason for Recall: On 06/22/2011 Novomedicus, FL initiated a recall of the Artificial Bur Hypopack Lot 1010.1, 1102.1, 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk.
• FDA Determined Cause: Process change control
• Action: Novomedicus sent a Medical Device Correction letter dated June 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy the inventory, or return the inventory to Novomedicus. If customers decided to return the remaining inventory, Novomedicus would provide TWO replacement kits for each one returned at no additional cost. Customers were asked to complete the attached Return Response form and return to NovoMedicus using the self-addressed and stamped envelope included. For questions regarding this recall call 941-375-4108.
• Quantity in Commerce: 37 kits
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTL