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FDA Medical Device Recalls (openFDA)

Kimberly-Clark Corporation: Kimberly Clark * Nerve 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

Recall number
Z-0866-06
Recalling firm
Kimberly-Clark Corporation
Product
Kimberly Clark * Nerve 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
Status
Terminated
Initiated
2006-03-15
Posted
2006-05-16
Terminated
2011-05-10
Reason
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
Other
Action
Consignees were notified via fax on/about 03/15/2006.
Quantity
270 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.
Lot, serial or model codes
Product Code: 18164, Lot #330105, Product Code: 181027, Lot #327294,  Product Code: 181A040, Lot #324535, Product Code: 181A108, Lot #326465, Product Code: 181A144, Lot #327309, Product Code: 181A170, Lot #328365
510(k) numbers
["K904440"]
PMA numbers
not on file
Product code
CAZ
Firm FEI
1000015879
Firm city
Roswell
Firm state
GA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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