Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0867-06

Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical...

Kimberly-Clark Corporation / initiated 2006-03-15 / Terminated / root cause: sterility

Kimberly-Clark Corporation began a recall of Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in... on . The reason FDA records is "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)". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-0867-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Kimberly-Clark Corporation
Product
Kimberly Clark * Nerve Root 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
Product code
CAZ Anesthesia Conduction Kit
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).
Root cause tag
sterility
FDA root cause
Other
Action
Consignees were notified via fax on/about 03/15/2006.
Quantity in commerce
650 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.
Product codes and lots
Product Code: 181236, Lot #324523