Z-1691-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,040 kits
Product Description
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Reason for Recall
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Distribution Pattern
Worldwide - US Nationwide and the countries of Canada.
Code Information
1. UDI-DI 10198459016257 (ea) 40198459016258 (case) 2. UDI-DI 10193489860078 (ea) 40193489860079 (case) ALL LOTS