Recalls & safety alerts
Stay informed about recalls and safety alerts issued for products used in veterinary medicine, animal foods, or other animal-related items. AVMA tracks this information and reports recalls and alerts as soon as they are verified. Follow the AVMA on social media to add updates to your social scroll.
FDA provides update on plastic syringes made in China, issues warning letters related to violative products
Recall date
Brand
Jiangsu Shenli Medical Production Co. Ltd.; Medline Industries, LP; Sol-Millennium Medical, Inc.Lot code/Notes
Until further notice and because of potential quality and performance issues,- Immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.
- Immediately transition away from using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd, which includes all models other than the 5 mL luer lock syringe, unless use of these syringes is absolutely necessary until you can complete the transition.
For all other plastic syringes made in China, while the FDA’s evaluation remains ongoing, we continue to recommend the following:
- Check the manufacturing location for syringes you use or have in your inventory by reviewing the labeling, outer packaging, or contacting your supplier or group purchasing organization.
- Use syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included.
- If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.
- Report any issues with syringes to the FDA.
Click the 'Additional Informational' link below for more information.
Reason
As such, on March 18, 2024, the FDA issued a warning letter to Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, and warning letters to Medline Industries, LP and Sol-Millennium Medical, Inc., two firms marketing and distributing plastic syringes made in China within the U.S. All three warning letters describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for use in the U.S. The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also concern violations related to quality system regulations for syringe products. The FDA expects these entities to fully address the violations described in the warning letters.
In addition, the FDA is actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co. Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP. The FDA is aware of performance testing that showed unexpected and unexplained failures with several Jiangsu Caina plastic syringes. The FDA evaluation is ongoing and we will take additional steps as appropriate.
In addition, the FDA is actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co. Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP. The FDA is aware of performance testing that showed unexpected and unexplained failures with several Jiangsu Caina plastic syringes. The FDA evaluation is ongoing and we will take additional steps as appropriate.