Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
FDA Recall Z-1184-2021 · Posted 2021-03-08
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusOpen, Classified
Product CodeLJT
Date Initiated2021-01-13
Product Quantity96 pieces total (updated 3/11/2021 additional 72 pieces)
Reason for Recall
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.
Firm Action
On 1/13/2021 and 02/10/2021, Medical Components issued an Urgent Medical Device Removal notification to customers via letter notifying customers 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. (updated 3/11/2021)
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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