FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: 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
- Recall number
- Z-0869-06
- Recalling firm
- Kimberly-Clark Corporation
- Product
- 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
- 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
- 2320 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: 181000, Lot #324507, Product Code: 181053, Lot #325536 Product Code: 181066, Lot #327295, Product Code: 181069, Lot #326447 & Lot #330094, Product Code: 181126, Lot #327296, Product Code: 181128, Lot #324516, Product Code: 181167, Lot #319874, Product Code: 181253, Lot #326455, Product Code: 181255, Lot #330100, Product Code: 181269, Lot #326456, Product Code: 181A055, Lot #329119, Product Code: 181A088, Lot #328354 and Product Code: 181A237, Lot #329220
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06