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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays see related information
Date Initiated by Firm March 15, 2006
Date Posted May 16, 2006
Recall Status1 Terminated 3 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/
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Richard V. Wolfe
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 2
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