The medical device company also reported 4th-quarter profit growth of more than 45%, beating Wall Street’s earnings expectations.
The recall was issued over reports that cracks had been discovered in some of the devices, which could interfere with patients receiving sufficient amounts of gases such as oxygen, according to the FDA.
The FDA classified the recall as Class I over concerns that continued use could result in serious injury or death.
Teleflex’s first recall, issued Dec. 4, 2014, covered only 3 lots of the product distributed in Florida, Kansas, Michigan and West Virginia from June 2013 through November 2014. The recall was expanded Jan. 12 to include 6 lots distributed in those states during that time.
All of the recalled lots were manufactured between September 2012 and September 2013. The FDA lists the manufacturer as Inmed, a Teleflex subsidiary based in Ireland.
Teleflex has advised healthcare facilities to immediately quarantine any recalled product, according to the safety watchdog.
Last fall, Teleflex issued a Class I recall for its Hudson RCI pediatric anesthesia devices over concerns that certain components could break during use.
Q4 earnings beat forecasts
Teleflex also reported its 4th-quarter and full-year results, beating expectations with its Q4 earnings on the strength of a 45.4% jump in profits compared with Q4 2013.
The Wayne, Pa.-based company reported profits of $50.6 million, or $1.07 per share, on sales growth of 5.7% to $476.0 million for the 3 months ended Dec. 31, 2014. Adjusted to exclude 1-time items, earnings per share were $1.43, 4¢ ahead of Wall Street’s forecast.
Full-year profits grew 24.4% to $187.7 million, or $4.04 per share, on sales growth of 8.5% to $1.84 billion. Adjusted EPS were $5.74.
"Teleflex’s full-year 2014 results demonstrate another successful year for the company," chairman, president & CEO Benson Smith said in prepared remarks. "We integrated Vidacare and Mayo Healthcare, delivered constant currency revenue growth near the upper end of our guidance range, and generated adjusted earnings per share well ahead of our initial expectations."
Teleflex said it expects to post adjusted EPS of $6.10 to $6.35 on sales growth of 4% to 6% on a constant currency basis.
"During 2015, we expect to continue to produce solid constant currency revenue growth and significant operating leverage. While we anticipate that our 2015 results will be negatively impacted by foreign exchange movements, we are committed to implementing operational measures to, in part, mitigate the earnings effect," Benson said.