FDAFDA · Food and drugs·Recall number Z-2592-2014
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.
Published September 10, 2014 · Recall initiated: August 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- USA Nationwide Distribution
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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