RecallDepth

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

This recall has been terminated (originally issued May 16, 2006).

Company
Kimberly-Clark Corporation
Recall Initiated
March 15, 2006
Posted
May 16, 2006
Terminated
May 10, 2011
Recall Number
Z-0865-06
Quantity
20 each
Firm Location
Roswell, GA
Official Source
View on FDA website ↗

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).

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.

Lot / Code Info

Product Code: 18146, Lot #330104

Root Cause

Other

Action Taken

Consignees were notified via fax on/about 03/15/2006.

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