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.
- Recall Initiated
- August 4, 2014
- Posted
- September 4, 2014
- Terminated
- December 10, 2014
- Recall Number
- Z-2592-2014
- Quantity
- 110
- Firm Location
- Harleysville, PA
Reason for Recall
The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
Distribution
USA Nationwide Distribution
Lot / Code Info
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.
Root Cause
Labeling False and Misleading
Action Taken
Medcomp sent a Recall Notification letter, dated August 4, 2014, to all affected customers. The letter identified the affected product, problem, and action to be taken. Customers were requested to respond and return all affected product. For questions call contact Susan Smith at ssmith@medcompnet.com.
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