The Recall Desk
HighFDA (Devices)·Z-0804-2018·Announced 2018-03-07

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

ConMed Corporation is recalling STAT 2 I.V. Gravity Flow Controllers and administration 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 risk-of-harm product (inaccurate flow rates in medical devices) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

ConMed Corporation is recalling approximately 1,612,440 units of STAT 2 I.V. Gravity Flow Controllers, Primary and Secondary Administration Sets, and Extension Sets. The affected products include specific catalog numbers such as S2, S2-12, S2-20 MD, S2V-20, and S2V-60, manufactured between April 27, 2012, and April 7, 2017.

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 products were distributed nationwide in the United States, including Puerto Rico, as well as in Lebanon, Panama, Saudi Arabia, Germany, India, and Canada. Consumers and healthcare providers should stop using these devices and contact ConMed Corporation for further instructions.

The recalled product

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 Con
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 (17)

  • Catalog Number
  • Manufacturing Date range
  • Lot Code range: (1) S2
  • 4/27/12 - 2/1/17
  • 120427X - 201702014
  • (2) S2-12
  • 4/27/12 - 3/13/17
  • 120427X - 201703134
  • (3) S2-20 MD
  • 4/27/12 - 1/2/17
  • 120427X - 201701024
  • (4) S2V-20
  • 4/27/12 - 4/7/17
  • 120427X - 201704074
  • and (5) S2V-60
  • 4/27/12 - 3/16/17
  • 120427X - 201703164

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 →

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