MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
FDA Recall Z-1868-2012 · Posted 2012-06-26
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJT
Date Initiated2012-04-02
Date Terminated2013-05-20
Product Quantity30
Reason for Recall
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Firm Action
MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
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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