Class 2 Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays

• Date Initiated by Firm: March 15, 2006
• Date Posted: May 16, 2006
• Recall Status: Terminated on May 10, 2011
• Recall Number: Z-0865-06
• Recall Event ID: 35158
• 510(K)Number: K904440
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA
• Code Information: Product Code: 18146, Lot #330104
• Recalling Firm/ Manufacturer: Kimberly-Clark Corporation; 1400 Holcomb Bridge Rd; Roswell GA 30076
• For Additional Information Contact: Richard V. Wolfe; 770-587-8208
• Manufacturer Reason for Recall: Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device).
• FDA Determined Cause: Other
• Action: Consignees were notified via fax on/about 03/15/2006.
• Quantity in Commerce: 20 each
• Distribution: Nationwide. AK, AL, CA, CO, CT, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, OK, OR, PA, TX, UT, WA, WI.
• 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 = CAZ and Original Applicant = PREFERRED MEDICAL PRODUCTS