Class 2 Device Recall Kendall

• Date Initiated by Firm: January 08, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-0380-04
• Recall Event ID: 28090
• 510(K)Number: K990530
• Product Classification: Dressing, Wound, Occlusive - Product Code NAD
• Product: Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331
• Code Information: Lot Number: 33492700
• Recalling Firm/ Manufacturer: Kendall Healthcare Products Co; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Gail Christie; 508-261-8530
• Manufacturer Reason for Recall: Sterility compromised due to lack of package seal integrity
• FDA Determined Cause: Other
• Action: Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.
• Quantity in Commerce: 1 case
• Distribution: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.
• 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 = NAD