Z-0864-06

Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard...

Name: Z-0864-06 Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard...
Creator: Kimberly-Clark Corporation
Published: 2006-03-15
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2006-03-15 / Terminated / root cause: sterility

FDA source

Kimberly-Clark Corporation began a recall of Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed... on 2006-03-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0864-06
Status: Terminated
Initiated: 2006-03-15
Posted: 2006-05-16
Terminated: 2011-05-10
Recalling firm: Kimberly-Clark Corporation
Product: 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.
Product code: FPK Tubing, Fluid Delivery
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).
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were notified via fax on/about 03/15/2006.
Quantity in commerce: 925 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.
Product codes and lots: Product Code: 18938, Lot #321922

Product code FPK

K935642Class IIEvans Medical Extension SetsEvans Medical, Inc. / cleared 1994-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)