Z-0072-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2012
- Initiation Date
- September 26, 2012
- Termination Date
- April 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,000 sets
Product Description
***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Reason for Recall
This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by
Distribution Pattern
Nationwide Distribution including California
Code Information
Product Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.