Recall Z-2939-2018— Medical Components, Inc dba MedComp
Class II · Terminated
Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2018-07-12, terminated 2020-07-02. It names 2 FDA 510(k) clearances: K983511, K842416. Product: SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424. Reason: 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..
- Recalling firm
- Medical Components, Inc dba MedComp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-12
- Terminated
- 2020-07-02
- Firm location
- Harleysville, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K983511 — SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
- K842416 — DUO FLOW CATHETER-MC 54
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.