Recall Z-2532-2015— Covidien LLC

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2015-08-06, terminated 2017-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 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

Product description

Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 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.