8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.
FDA Recall Z-1626-2012 · Posted 2012-05-18
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJT
Date Initiated2012-04-12
Date Terminated2013-07-18
Product Quantity50 trays
Reason for Recall
50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Firm Action
On April 12, 2012, MedComp sales representatives and the foreign distributor were notified via e-mail with a "Product Alert" notification. The issue was described and requested actions were provided to recipients.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - - USA, including the states of CA, NJ, AZ, PA, TN and the country of Spain.
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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