Device product
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.
Z-0371-2020
Product summary
- Event
- Event 84021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 cases (208 units) total
- Official record key
device-enforcement:Z-0371-2020
Official wording
Reason: The connector piece to the PEG tube does not pass over the guidewire.
Code information: Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)
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.