Recall Z-0864-06 ยท FPK Tubing, Fluid Delivery
Kimberly-Clark Corporation
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.
| Date | May 16, 2006 (initiated Mar 15, 2006) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | Consignees were notified via fax on/about 03/15/2006. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935642 | EVANS MEDICAL EXTENSION SETS Evans Medical, Inc., Jan 28, 1994 |