Class 3 Device Recall V.A.C. ATS Wound Healing System

• Date Initiated by Firm: September 16, 2005
• Date Posted: January 11, 2006
• Recall Status: Terminated on February 21, 2006
• Recall Number: Z-0379-06
• Recall Event ID: 34310
• 510(K)Number: K032310
• Product Classification: Apparatus, Suction, Ward Use, Portable, Ac-Powered - Product Code JCX
• Product: V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
• Code Information: Lot #08150506M
• FEI Number: 1625774
• Recalling Firm/ Manufacturer: Kinetic Concepts, Inc; 4958 Stout Dr; San Antonio TX 78219-4334
• Manufacturer Reason for Recall: Possible mislabeling of shipping cartons.
• FDA Determined Cause: Other
• Action: All hospitals and nursing homes contacted via letter and by phone.
• Quantity in Commerce: 64 cartons.
• Distribution: Product distributed nationwide to hospitals and nursing homes in the following states: AL, AZ, CA, CO, CT, FL, IL, IN, KY, MA, NC, NY, OK, PA, SC, and TX.
• 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 = JCX