medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
FDA Recall Z-2235-2010 · Posted 2010-08-17
Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJT
Date Initiated2010-07-02
Date Terminated2010-10-13
Product Quantity47 units
Reason for Recall
Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
Firm Action
Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
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.