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Cardinal Health (CAH) Gets FDA Warning for Monoject Syringes
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Cardinal Health’s (CAH - Free Report) Monoject syringes get unfavorable FDA recommendation following reports of delay in therapy as well as inaccurate therapy (overdose or underdose) when used with a syringe pump or a patient-controlled analgesia (PCA) pump.
In September, Cardinal Health initiated a recall for certain Monoject single-use Luer-lock tip syringes due to incompatibility with syringe pumps. The FDA classified it as the most serious type of recall, implying that the use of these syringes with syringe pumps may cause serious injuries or death.
Cardinal Health Monoject disposable syringes are used to inject into or withdraw fluids from the body. When used with syringe pumps and PCA pumps, disposable syringes are loaded with fluid or medications and placed into the pump. Cardinal Health started distributing Monoject syringes in June 2023 that are also available under the brand name Covidien.
Price Performance
Shares of Cardinal Health have risen this week despite unfavorable FDA recommendation. This is likely because Monoject syringes is a recent franchise, which is unlikely to have any significant impact on the company’s top and bottom lines. Shares of Cardinal Health have risen 37.7% year to date compared with the industry's 8% growth. The S&P 500 Index has increased 19.7% in the same period.
Image Source: Zacks Investment Research
Incompatibility Issue
Cardinal Health’s Monoject syringes have different dimensions from the Covidien Monoject syringes. The syringe pump or PCA pump is compatible with the dimensions of Covidien Monoject syringes. The dimensional changes made by Cardinal Health have raised concerns about incompatibility, non-recognition and pump performance issues such as overdose, underdose, and delay in therapy and occlusion alarms.
Although CAH initiated a recall for syringes that are used with syringe pumps, the FDA is concerned about the risk of incompatibility of Cardinal Health Monoject syringes when used with other pumps, specifically PCA pumps. The regulatory body has also raised concerns about the risk of incompatibility of Cardinal Health’s Monoject syringes of additional dimensions not included in the recall.
The FDA has recommended against the use of Cardinal Health Monoject syringes with syringe pumps or PCA pumps. The FDA recommendation only includes Monoject syringes distributed by Cardinal Health. Monoject syringes with the brand name Covidien are allowed to be used with syringe pumps or PCA pumps.
The FDA is currently working with CAH to address its concerns and identify additional mitigation strategies as needed.
Recent Developments
Last month, Cardinal Health announced the launch of its next-generation Kangaroo OMNI enteral feeding pump in the United States. The new pump’s design will provide more options to patients in meeting their personalized needs for enteral feeding.
The same month, the company reported its first-quarter fiscal 2024 results, wherein it recorded a solid uptick in its overall top line. The company also witnessed revenue growth in its Pharmaceutical segment. Recovery in the Medical segment was encouraging.
Currently, Cardinal Health carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Biodesix (BDSX - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 18.3%. DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 36.55%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have risen 33.2% year to date compared with the industry’s 2.6% growth.
Biodesix, carrying a Zacks Rank of 2 at present, has an estimated growth rate of 32.3% for 2024. BDSX’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 9.76%.
Biodesix’s shares have lost 35.2% year to date compared with the industry’s 11% decline.
Integer Holdings, sporting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.
Integer Holdings’ shares have rallied 30.4% year to date against the industry’s 5.4% decline.
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Cardinal Health (CAH) Gets FDA Warning for Monoject Syringes
Cardinal Health’s (CAH - Free Report) Monoject syringes get unfavorable FDA recommendation following reports of delay in therapy as well as inaccurate therapy (overdose or underdose) when used with a syringe pump or a patient-controlled analgesia (PCA) pump.
In September, Cardinal Health initiated a recall for certain Monoject single-use Luer-lock tip syringes due to incompatibility with syringe pumps. The FDA classified it as the most serious type of recall, implying that the use of these syringes with syringe pumps may cause serious injuries or death.
Cardinal Health Monoject disposable syringes are used to inject into or withdraw fluids from the body. When used with syringe pumps and PCA pumps, disposable syringes are loaded with fluid or medications and placed into the pump. Cardinal Health started distributing Monoject syringes in June 2023 that are also available under the brand name Covidien.
Price Performance
Shares of Cardinal Health have risen this week despite unfavorable FDA recommendation. This is likely because Monoject syringes is a recent franchise, which is unlikely to have any significant impact on the company’s top and bottom lines. Shares of Cardinal Health have risen 37.7% year to date compared with the industry's 8% growth. The S&P 500 Index has increased 19.7% in the same period.
Image Source: Zacks Investment Research
Incompatibility Issue
Cardinal Health’s Monoject syringes have different dimensions from the Covidien Monoject syringes. The syringe pump or PCA pump is compatible with the dimensions of Covidien Monoject syringes. The dimensional changes made by Cardinal Health have raised concerns about incompatibility, non-recognition and pump performance issues such as overdose, underdose, and delay in therapy and occlusion alarms.
Although CAH initiated a recall for syringes that are used with syringe pumps, the FDA is concerned about the risk of incompatibility of Cardinal Health Monoject syringes when used with other pumps, specifically PCA pumps. The regulatory body has also raised concerns about the risk of incompatibility of Cardinal Health’s Monoject syringes of additional dimensions not included in the recall.
The FDA has recommended against the use of Cardinal Health Monoject syringes with syringe pumps or PCA pumps. The FDA recommendation only includes Monoject syringes distributed by Cardinal Health. Monoject syringes with the brand name Covidien are allowed to be used with syringe pumps or PCA pumps.
The FDA is currently working with CAH to address its concerns and identify additional mitigation strategies as needed.
Recent Developments
Last month, Cardinal Health announced the launch of its next-generation Kangaroo OMNI enteral feeding pump in the United States. The new pump’s design will provide more options to patients in meeting their personalized needs for enteral feeding.
The same month, the company reported its first-quarter fiscal 2024 results, wherein it recorded a solid uptick in its overall top line. The company also witnessed revenue growth in its Pharmaceutical segment. Recovery in the Medical segment was encouraging.
Cardinal Health, Inc. Price
Cardinal Health, Inc. price | Cardinal Health, Inc. Quote
Zacks Rank & Other Stocks to Consider
Currently, Cardinal Health carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Biodesix (BDSX - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 18.3%. DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 36.55%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have risen 33.2% year to date compared with the industry’s 2.6% growth.
Biodesix, carrying a Zacks Rank of 2 at present, has an estimated growth rate of 32.3% for 2024. BDSX’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 9.76%.
Biodesix’s shares have lost 35.2% year to date compared with the industry’s 11% decline.
Integer Holdings, sporting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.
Integer Holdings’ shares have rallied 30.4% year to date against the industry’s 5.4% decline.