Recall Z-1210-2016 ยท EZL Catheter, Retention Type, Balloon
Covidien LLC
Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
| Date | Mar 21, 2016 (initiated Jan 22, 2016) |
| Status | Terminated |
| Reason | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000. |
| Quantity | 7200 |
| Distribution | US (nationwide) and to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND Primary Care Solutions, Inc., May 30, 2003 |
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR Degania Silicone , Ltd., Mar 26, 2007 |
| K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) Riverstone Resources Sdn Bhd, Jul 16, 2010 |