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Terminated

Kimberly 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

FDA Recall Z-0869-06 · Posted 2006-05-16

Recalling FirmKimberly-Clark Corporation
Recall StatusTerminated
Product CodeCAZ
Date Initiated2006-03-15
Date Terminated2011-05-10
Product Quantity2320 each

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).

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.

K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITSPreferred Medical Products · 1991-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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