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All product recalls associated with Medical Components, Inc dba MedComp.
Total Recalls
8
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2021
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.