The Recall Desk
HighFDA (Devices)·Z-0805-2018·Announced 2018-03-07

ConMed Recalls STAT 2 I.V. Gravity Flow Sets Due to Inaccurate Flow Rates

ConMed is recalling STAT 2 I.V. Gravity Flow Needle-Free Controller sets because they exhibit inaccurate or inconsistent flow rates.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device with a functional defect (inaccurate flow rates) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ConMed Corporation is recalling STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets. The affected products include catalog numbers S2-12 N, S2V-20 N, and S2V-60 N. The recall covers 1,612,440 units in total.

The recall was initiated because the intravascular fluid administration sets are exhibiting inaccurate or inconsistent flow rates. These devices are used to control the infusion of intravenous fluids into the human body.

The affected products were distributed nationwide in the United States, including Washington, DC, and Puerto Rico, as well as in Lebanon, Panama, Saudi Arabia, Germany, India, and Canada. Consumers and healthcare providers should stop using the affected products and contact ConMed Corporation for instructions on return or replacement.

The recalled product

Product
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-
Manufacturer
ConMed Corporation
Category
Medical Device — IV Administration Sets
Hazard
Affected units
1,612,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Catalog Number
  • Manufacturing Date range
  • Lot Code range: (1) S2-12 N
  • 4/27/12 - 4/12/17
  • 120427X - 201704124
  • (2) S2V-20 N
  • 4/27/12 - 11/7/17
  • 120427X - 201611074
  • and (3) S2V-60 N
  • 4/27/12 - 2/13/17
  • 120427X - 201702134

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · inaccurate flow rate

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