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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 Trayssee related information
Date Initiated by FirmMarch 15, 2006
Date PostedMay 16, 2006
Recall Status1 Terminated 3 on May 10, 2011
Recall NumberZ-0869-06
Recall Event ID 35158
510(K)NumberK904440 
Product Classification Anesthesia Conduction Kit - Product Code CAZ
ProductKimberly Clark * Universal 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: 181000, Lot #324507, Product Code: 181053, Lot #325536 Product Code: 181066, Lot #327295, Product Code: 181069, Lot #326447 & Lot #330094, Product Code: 181126, Lot #327296, Product Code: 181128, Lot #324516, Product Code: 181167, Lot #319874, Product Code: 181253, Lot #326455, Product Code: 181255, Lot #330100, Product Code: 181269, Lot #326456, Product Code: 181A055, Lot #329119, Product Code: 181A088, Lot #328354 and  Product Code: 181A237, Lot #329220 
FEI Number 1000015879
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information ContactRichard 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 2		Other
ActionConsignees were notified via fax on/about 03/15/2006.
Quantity in Commerce2320 each
DistributionNationwide. 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 CycleTPLC 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) Database510(K)s with Product Code = CAZ
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