Z-3073-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- June 23, 2017
- Termination Date
- April 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 boxes of 10 individual units
Product Description
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
Reason for Recall
Inadequate detectability of radiopaque stripes
Distribution Pattern
TX, VA, IL, CA, KS
Code Information
a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010