Recall Z-2536-2015— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2015-08-06, terminated 2017-06-29. It names one FDA 510(k) clearance: K060339. Product: MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.. Reason: Sterility may be compromised.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-06
- Terminated
- 2017-06-29
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's record- K060339 — KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
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
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Reason for recall
Sterility may be compromised
Data sourced from openFDA. This site is unofficial and independent of the FDA.