9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Class I - DangerousWhat Should You Do?
- Check if you have this product: MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medical Components, Inc dba MedComp
- Reason for Recall:
- The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Product Codes/Lot Numbers:
MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
Distribution:
Distributed in: PR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1536-2017
Related Recalls
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Medical Components, Inc
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Medical Components, Inc
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
C3 Wave App, v. 2.0.5
Medical Components, Inc
When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.