Z-0371-2020 Class II Terminated
FDA device recall Z-0371-2020 was initiated by Avanos Medical, Inc. on October 8, 2019 and is designated Class II. Reason for recall: The connector piece to the PEG tube does not pass over the guidewire. The recall status is terminated (terminated March 16, 2022). Affected quantity: 104 cases (208 units) total.
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 with ENFit Connector. 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: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)