PlainRecalls
FDA Devices Moderate Class II Terminated

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Reported: September 9, 2015 Initiated: August 6, 2015 #Z-2535-2015

Product Description

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP 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

Details

Recalling Firm
Covidien LLC
Units Affected
569 kits
Distribution
US Nationwide Distribution
Location
North Haven, CT

Frequently Asked Questions

What product was recalled?
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.. Recalled by Covidien LLC. Units affected: 569 kits.
Why was this product recalled?
Sterility may be compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2535-2015.