Device product
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.
Z-0370-2020
Product summary
- Event
- Event 84021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 cases (208 units) total
- Official record key
device-enforcement:Z-0370-2020
Official wording
Reason: The connector piece to the PEG tube does not pass over the guidewire.
Code information: Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)
Distribution pattern: Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.
Derived failure modes
-
Unknown
The connector piece to the PEG tube does not pass over the guidewire.