Reported Mar 7, 2018 · Terminated
STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1)…
ConMed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945
Is this the product you have?
- STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets
- and Extension Sets (Catalog Numbers(1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 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
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Catalog Number, Manufacturing Date range, Lot Code range: (1) S2-12 N,4/27/12 - 4/12/17, 120427X - 201704124 2 (2) S2V-20 N, 4/27/12 - 11/7/17, 120427X - 201611074 3 and (3) S2V-60 N, 4/27/12 - 2/13/17, 120427X - 201702134 - Amount recalled
- 1,612,440in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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