Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Class I - DangerousWhat Should You Do?
- Check if you have this product: MKAZ210 MCBK870 MCBS910 MCBZ450 MCCP990 MCCZ440 MCDNlOO MCDQ930 MCFD710 MCFN970 MCFS730 MCAS340 MCBA830 MCBR880 MCBY910 MCCF130 MCCX150 MCDF010 MCDG980 MCDP120 MCFD720 MCFJ060 MCFM520 MCFW300 MCFZ590 MKAJ380 MCAS230 MCBL150 MCBN500 MCBZ380 MCCV010 MCDF030 MCFX080 MCFV620 MCBA170 MCDC940 MKAX240 MCAC870 MCCQ000 MCFG380 MKAQ920 MCAH920 MCCW950
- 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 suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Product Codes/Lot Numbers:
MKAZ210 MCBK870 MCBS910 MCBZ450 MCCP990 MCCZ440 MCDNlOO MCDQ930 MCFD710 MCFN970 MCFS730 MCAS340 MCBA830 MCBR880 MCBY910 MCCF130 MCCX150 MCDF010 MCDG980 MCDP120 MCFD720 MCFJ060 MCFM520 MCFW300 MCFZ590 MKAJ380 MCAS230 MCBL150 MCBN500 MCBZ380 MCCV010 MCDF030 MCFX080 MCFV620 MCBA170 MCDC940 MKAX240 MCAC870 MCCQ000 MCFG380 MKAQ920 MCAH920 MCCW950
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2936-2018
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.