9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
FDA Recall Z-1527-2015 · Posted 2015-04-27
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJT
Date Initiated2015-01-28
Date Terminated2017-01-06
Product Quantity325
Reason for Recall
The dual port with catheters was not covered under FDA clearance.
Firm Action
Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.
Root Cause
PMA
Distribution Pattern
Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
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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