Recall Z-0804-2018— ConMed Corporation

Name: FDA recall Z-0804-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-19

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2017-06-19, terminated 2022-07-25. It names one FDA 510(k) clearance: K905498. Product: STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.. Reason: Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates..

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-19
Terminated: 2022-07-25
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K905498 — STAT 2 IV PUMPETTEThe Master Medical Corp.·cleared 1991-04-16

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

STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2¿ Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.

Reason for recall

Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.