Class 2 Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain

• Date Initiated by Firm: July 27, 2011
• Date Posted: September 08, 2011
• Recall Status: Terminated on February 16, 2012
• Recall Number: Z-3172-2011
• Recall Event ID: 59453
• 510(K)Number: K080357
• Product Classification: Wound Dressing Kit - Product Code MCY
• Product: Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
• Code Information: product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; Mchenry IL 60050-7006
• For Additional Information Contact: Mr. Donald J. Alexander; 815-578-2406
• Manufacturer Reason for Recall: Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".
• FDA Determined Cause: Error in labeling
• Action: Medela Inc. sent an "Urgent Device Recall" letter dated July 26, 2011 to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.
• Quantity in Commerce: 3,000 kits
• Distribution: Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
• 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 = MCY