SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Reported: September 5, 2018 Initiated: July 12, 2018 #Z-2939-2018
Product Description
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
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? ▼
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424. 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-2939-2018.
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