Z-2979-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- April 12, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 kits
Product Description
Cardiac Insulation Pad, OPEN HEART CDS
Reason for Recall
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.
Distribution Pattern
CA, NM
Code Information
Model: CDS984745C; Lots: 17GD0936, 17FD1655, 17ED3419, 17ED1482, 17ED0636, 17DD0666, 17DD0296, 17AD1912, 16LD3005, 16LD0059, 16JD3201, 16ID3179, 16HD1298, 16GD0779, 16FD3925, 16CD0303 and 16AD4032