Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Reported: September 5, 2018 Initiated: July 12, 2018 #Z-2936-2018
Product Description
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
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.
Details
- Recalling Firm
- Medical Components, Inc dba MedComp
- Units Affected
- N/A
- Distribution
- Nationwide distribution; worldwide distribution.
- Location
- Harleysville, PA
Frequently Asked Questions
What product was recalled? ▼
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits. Recalled by Medical Components, Inc dba MedComp. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2936-2018.
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