Kimberly Clark * 20' Minibore Extension Line * 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 is a Pain Management Product that is sold in a wide variety of kits including both standard tray configurations and custom kits.
FDA Recall Z-0864-06 · Posted 2006-05-16
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Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeFPK
Date Initiated2006-03-15
Date Terminated2011-05-10
Product Quantity925 each
Reason for Recall
There exists a possibility that the Pain Management 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).
Firm Action
Consignees were notified via fax on/about 03/15/2006.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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