Device product
Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
Z-2592-2014
Product summary
- Event
- Event 68993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110
- Official record key
device-enforcement:Z-2592-2014
Official wording
Reason: The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
Code information: TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Labeling or packaging
incorrectly labeled