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.
Reported: May 6, 2015 Initiated: January 28, 2015 #Z-1527-2015
Product Description
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.
Reason for Recall
The dual port with catheters was not covered under FDA clearance.
Details
- Recalling Firm
- Medical Components, Inc dba MedComp
- Units Affected
- 325
- Distribution
- Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
- Location
- Harleysville, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medical Components, Inc dba MedComp. Units affected: 325.
Why was this product recalled? ▼
The dual port with catheters was not covered under FDA clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1527-2015.
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