Smiths Medical recall affects nearly 86,000 syringe pumps with software issues

Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions.

The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump recall on Dec. 19, 2023. The recall affects all those exposed to the pump, especially vulnerable patients. That includes those in the neonatal intensivecare unit (NICU) and cardiac intensive care unit (CICU) treated with Medfusion 3500.

Smiths Medical reports one injury and no deaths related to this issue, according to an FDA notice.

This latest recall follows last month’s FDA Class I recall for more than 50,000 Medfusion Model 4000 pumps. Similarly, the company recalled those models due to a software issue.

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Smiths Medical issues urgent device correction for some CADD infusion pumps

Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system.

The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.

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ICU Medical beats The Street in Q1

ICU Medical (Nasdaq:ICUI) reported first-quarter results that came in ahead of the consensus earnings per share forecast.

The San Clemente, California-based company posted losses of $38.1 million, or $1.61 per share, on sales of $543.1 million for the three months ended March 31, 2022, for a bottom-line slide into the red on sales growth of 70.8%.

Adjusted to exclude one-time items, earnings per share were $1.82, 4¢ ahead of projections on Wall Street, where analysts were looking for sales of $543.1 million.

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ICU Medical beats The Street in Q4, posts full-year guidance

ICU Medical (NASDAQ:ICUI) shares rose today on fourth-quarter results that came in ahead of the consensus forecast.

The San Clemente, California-based company posted profits of $19.9 million, or 91¢ per share, on sales of $340.5 million for the three months ended Dec. 31, 2021, for a 23.8% bottom-line slide on sales growth of 6.3%.

Adjusted to exclude one-time items, earnings per share were $1.82, 18¢ ahead of Wall Street, where analysts were looking for sales of $323.9 million.

“Fourth-quarter results were generally in line with our expectations,” ICU Medical CEO Vivek Jain said in a news release.

ICU Medical said it expects to log adjusted EPS of between $9 and $10.50 for the full-year 2022. The company set its adjusted EBITDA guidance for between $450 million and $500 million. The company’s outlook does not reflect the impact of the pending purchase price allocation for the $2.35 billion acquisition of Smiths Medical completed earlier thi…

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ICU Medical’s Smiths Medical acquisition remains on track

ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group.

Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy.

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Smiths Medical has a Class I recall over aluminum potentially leaking in fluid warmers

Smiths Medical is recalling the Normoflo irrigation fluid warmer and warmer sets due to the potential for aluminum ions leaching into warmed fluids.

The recall has been designated as a Class I recall — the most serious kind — by the FDA.

According to an FDA notice, when fluid circulates through a patient’s body, the patient can be exposed to high levels of aluminum. That exposure may not be easily recognized and could lead to serious adverse events, including death. No complaints, injuries or reports of death have been received to date.

The recall covers the Normoflo irrigation fluid warmer and Normoflo irrigation warming set. The company initiated the recall on Aug. 6, 2021, for devices manufactured between January 1994 and July 2021 and distributed between January 1994 and the present day. To date, Smiths Medical has recalled 520,163 devices in the U.S.

Normoflo fluid warming systems warm blood, blood products and intravenous solutions bef…

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Smiths Medical recalls some insulin syringes over skewed graduation marking

[Image from Smiths Medical]Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes.

Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward by approximately 20 degrees.

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Smiths Medical partners with Ivenix on infusion management suite

Smiths Medical announced today that it partnered with Ivenix to offer a comprehensive suite of infusion management solutions.

Minneapolis-based Smiths Medical will provide a strategic investment for the long-term partnership that intends to “revolutionize” infusion management and improve patient safety while meeting the needs of healthcare providers, according to a news release.

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Smiths Medical has a serious infusion pump recall

Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected.

Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one of those doses is interrupted, followed by a specific sequence of events due to a software error. The issue could result in serious injury or death.

Affected models include the Medfusion 3500 syringe pump with firmware version 6.0.0 and the Medfusion 4000 syringe pump with firmware versions 1.5.0, 1.5.1, 1.6.0, 1.6.1 and 1.7.0. The FDA designated a recall of the devices as Class I, the most serious kind.

Smiths Medical distributed the affected models between 2013 and 2020. The company received four reports associated with the issue, all of which involved over-delivery of medication. One report resulted in a se…

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