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Cardinal Health's (CAH) China Syringe Makers Face FDA Warnings
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Cardinal Health’s(CAH - Free Report) Presource kit plastic syringe makers Jiangsu Shenli Medical Production Co. Ltd and Jiangsu Caina have been facing FDA investigation. Recent inspections have unveiled multiple quality system violations, leading to warning letters and import alerts. CAH has recalled the affected products to ensure patient safety and compliance with FDA regulations.
Following the recent warning, the import alert was expanded to preventJiangsu Shenli’s enteral syringes from entering the United States. The FDA has recommended an immediate transition away from using Jiangsu Shenli’s enteral syringes unless absolutely necessary. The regulatory body’s recommendation will lead to the use of enteral syringes manufactured by a different manufacturer.
Significance of the Warning
Per CAH, the FDA's findings underscore critical lapses in quality control and documentation at China-based Jiangsu Shenli and Jiangsu Caina, with severe implications for patient safety. Cardinal Health's recall highlights the widespread impact of these deficiencies, particularly regarding the Monoject syringes, which have been linked to performance failures and incompatibilities.
More on the News
In March, the FDA identified Jiangsu Shenli and Jiangsu Caina as targets in its investigation into the safety of Chinese-made plastic syringes. During a partial inspection of a Jiangsu Caina facility, the FDA noted quality issues and performance testing failures. Inspectors found no documentation for the design and development of syringes exported to the United States and also noted a lack of documentation for Jiangsu Shenli's enteral feeding syringes. Jiangsu Shenli's enteral feeding syringes were outside the original investigation's scope. Consequently, the FDA added these syringes to the import alert against Jiangsu Shenli and advised healthcare providers to promptly switch to alternative devices.
Last month, CAH had initiated a recall of plastic syringes produced by Jiangsu Shenli Medical Production Co. Ltd, which are incorporated in Merit Medical kits and included in Cardinal Health Resource kits, after it was found that the syringes do not have FDA clearance.
Industry Prospects
Per a report in Future Market Insights, the global plastic syringe market was valued at $3.6 billion in 2023. It is anticipated to reach $6.1 billion by 2033 at a CAGR of 5.3%.
The robust growth is due to a significant increase in demand for disposable syringes due to a rise in immunization programs supported by governments and healthcare organizations worldwide. The disposable plastic syringe industry has expanded significantly due to awareness and education campaigns in the healthcare sector.
The primary factors forcing the change are the simplicity of use and disposal of the syringe and a greater awareness of the value of preventing infections and cross-contamination.
Price Performance
Shares of CAH have declined 5.3% so far this year compared with no change for the industry. The S&P 500 witnessed a 15.8% rise in the same time frame.
Quest Diagnostics has an estimated long-term growth rate of 5.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.67%.
Quest Diagnostics shares have gained 3.2% compared with the industry’s 10.9% rise so far this year.
Universal Health Services has an estimated long-term growth rate of 15.20%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 8.12%.
Universal Health Services has gained 17.5% compared with the industry's 10.2% rise so far this year.
Haemonetics has an estimated long-term growth rate of 12.00%. HAE’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 13.24%.
Haemonetics’ shares have increased 7.1% compared with the industry's 3.2% rise so far this year.
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Cardinal Health's (CAH) China Syringe Makers Face FDA Warnings
Cardinal Health’s (CAH - Free Report) Presource kit plastic syringe makers Jiangsu Shenli Medical Production Co. Ltd and Jiangsu Caina have been facing FDA investigation. Recent inspections have unveiled multiple quality system violations, leading to warning letters and import alerts. CAH has recalled the affected products to ensure patient safety and compliance with FDA regulations.
Following the recent warning, the import alert was expanded to preventJiangsu Shenli’s enteral syringes from entering the United States. The FDA has recommended an immediate transition away from using Jiangsu Shenli’s enteral syringes unless absolutely necessary. The regulatory body’s recommendation will lead to the use of enteral syringes manufactured by a different manufacturer.
Significance of the Warning
Per CAH, the FDA's findings underscore critical lapses in quality control and documentation at China-based Jiangsu Shenli and Jiangsu Caina, with severe implications for patient safety. Cardinal Health's recall highlights the widespread impact of these deficiencies, particularly regarding the Monoject syringes, which have been linked to performance failures and incompatibilities.
More on the News
In March, the FDA identified Jiangsu Shenli and Jiangsu Caina as targets in its investigation into the safety of Chinese-made plastic syringes. During a partial inspection of a Jiangsu Caina facility, the FDA noted quality issues and performance testing failures. Inspectors found no documentation for the design and development of syringes exported to the United States and also noted a lack of documentation for Jiangsu Shenli's enteral feeding syringes. Jiangsu Shenli's enteral feeding syringes were outside the original investigation's scope. Consequently, the FDA added these syringes to the import alert against Jiangsu Shenli and advised healthcare providers to promptly switch to alternative devices.
Last month, CAH had initiated a recall of plastic syringes produced by Jiangsu Shenli Medical Production Co. Ltd, which are incorporated in Merit Medical kits and included in Cardinal Health Resource kits, after it was found that the syringes do not have FDA clearance.
Industry Prospects
Per a report in Future Market Insights, the global plastic syringe market was valued at $3.6 billion in 2023. It is anticipated to reach $6.1 billion by 2033 at a CAGR of 5.3%.
The robust growth is due to a significant increase in demand for disposable syringes due to a rise in immunization programs supported by governments and healthcare organizations worldwide. The disposable plastic syringe industry has expanded significantly due to awareness and education campaigns in the healthcare sector.
The primary factors forcing the change are the simplicity of use and disposal of the syringe and a greater awareness of the value of preventing infections and cross-contamination.
Price Performance
Shares of CAH have declined 5.3% so far this year compared with no change for the industry. The S&P 500 witnessed a 15.8% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, CAH carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the broader medical space are Quest Diagnostics (DGX - Free Report) , Universal Health Services (UHS - Free Report) and Haemonetics (HAE - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Quest Diagnostics has an estimated long-term growth rate of 5.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.67%.
Quest Diagnostics shares have gained 3.2% compared with the industry’s 10.9% rise so far this year.
Universal Health Services has an estimated long-term growth rate of 15.20%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 8.12%.
Universal Health Services has gained 17.5% compared with the industry's 10.2% rise so far this year.
Haemonetics has an estimated long-term growth rate of 12.00%. HAE’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 13.24%.
Haemonetics’ shares have increased 7.1% compared with the industry's 3.2% rise so far this year.