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Recall Observatory FDA recall evidence

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

August 04, 2014

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
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

    reason.labeling_packaging · v1.0.0

    incorrectly labeled