Z-0370-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 8, 2019
- Termination Date
- March 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 cases (208 units) total
Product Description
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
Reason for Recall
The connector piece to the PEG tube does not pass over the guidewire.
Distribution Pattern
Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Code Information
Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)