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Class 2 Device Recall Kimberly Clark/Ballard Medical Pain Management Procedural Trays |
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Date Initiated by Firm |
March 15, 2006 |
Date Posted |
May 16, 2006 |
Recall Status1 |
Terminated 3 on May 10, 2011 |
Recall Number |
Z-0866-06 |
Recall Event ID |
35158 |
510(K)Number |
K904440
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Product Classification |
Anesthesia Conduction Kit - Product Code CAZ
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Product |
Kimberly Clark * Nerve 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: 18164, Lot #330105, Product Code: 181027, Lot #327294, Product Code: 181A040, Lot #324535, Product Code: 181A108, Lot #326465, Product Code: 181A144, Lot #327309, Product Code: 181A170, Lot #328365 |
Recalling Firm/ Manufacturer |
Kimberly-Clark Corporation 1400 Holcomb Bridge Rd Roswell GA 30076
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For Additional Information Contact |
Richard V. Wolfe 770-587-8208
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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).
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via fax on/about 03/15/2006. |
Quantity in Commerce |
270 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
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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.
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510(K) Database |
510(K)s with Product Code = CAZ and Original Applicant = PREFERRED MEDICAL PRODUCTS
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