🔍 RecallPedia

Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Class I - Dangerous
🏥 Medical Devices Recalled: July 27, 2020 Medical Components, Inc Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Product Codes/Lot Numbers:

Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020

Distribution:

Distributed in: AZ, CA, FL, GA, NC, ND, NJ, NY, OH, PA, VA, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2940-2020

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

Class I - Dangerous

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.

Jan 13, 2021 Implants & Prosthetics Nationwide View Details →

C3 Wave App, v. 2.0.5

Medical Components, Inc

Class I - Dangerous

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.

Oct 1, 2018 Other Medical Devices View Details →