Sol-Millennium Syringe Recall Issued Amid FDA Crackdown on Plastic Chinese-Made Syringes

Recalled Chinese syringes were not approved by the FDA, and may be prone to leaking and breaking, causing life-threatening injuries and complications

Amid ongoing safety concerns linked to Chinese-made syringes, Sol-Millennium has issued a recall for several types of plastic syringes and syringe components also manufactured in China, which may pose serious health risks for patients.

The manufacturer announced the Sol-Millennium syringe recall on May 8. including low dead space syringes (LDS), luer slip tip syringes, and syringes with needle and syringe components packaged together.

The recall was issued after the U.S. Food and Drug Administration (FDA) informed Sol-Millennium that the syringes were not approved by the agency, since the design differed significantly from the syringes that were approved by the agency, indicating that the devices require FDA clearance before they can be used on patients.

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Chinese-Made Syringe Problems

The various types of plastic syringes made by Sol-Millennium are part of the ongoing problem affecting plastic syringes manufactured in China.

In late 2023, FDA regulators began investigating reports of Chinese plastic syringes leaking and breaking. Due to the quality and safety concerns, the FDA urged consumers and healthcare providers to transition away from the syringes while they continued to investigate the issue.

The FDA issued warning letters to syringe manufacturers Jiangsu Shenli Medical Production Co. Ltd., Medline Industries, LP, and Sol-Millennium Medical, Inc. in March of 2024. The federal agency later issued an import alert in April and recommended healthcare providers stop using plastic syringes from the listed manufacturers and any plastic syringes manufactured in China unless absolutely necessary.

These syringes are susceptible to leaking and breaking, causing patients to suffer life-threatening injuries and complications. The problems affecting the syringes can cause the product to deliver incorrect doses of medication, either less or more than what is needed. Receiving the incorrect dose can lead to serious complications, including death.

Sol-Millennium Syringe Recall

The Sol-Millennium recall affects 117 different models of plastic syringes manufactured in China and sold in the United States. A complete list of the affected lot numbers is listed in the company’s recall notice.

The company indicates the syringes should be quarantined from use and returned to the distributor. Sol-Millennium said it’s working with the FDA to submit the correct applications and clear the products for approval.

Side effects, injuries, and quality problems suffered from Sol-Millennium syringes should be reported to the FDA’s MedWatch Adverse Event Reporting program.

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