The FDA has announced added recalls initiated by Medline Industries, LP concerning plastic syringes manufactured in China. The recall aims to address issues with unauthorized syringes and those that have failed performance testing.
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Medline Industries, LP, has begun recalling syringes contained in convenience kits due to these concerns. Specifically, the FDA advises discontinuing the use of plastic syringes made by the following manufacturers:
- Jiangsu Caina Medical Co Ltd.
- Jiangsu Shenli Medical Production Co Ltd.
- Shanghai Kindly Enterprise Development Group Co Ltd.
- Zhejiang Longde Pharmaceutical Co Ltd.
Evaluating recalled plastic syringes
Users are urged to transition away from using these affected syringes immediately, unless absolutely necessary. The FDA continues to evaluate the situation and will provide ongoing updates as new information becomes available.
A comprehensive timeline and summary of activities related to this issue, including detailed recall actions, can be found in FDA Actions. The FDA’s recommendations remain unchanged. Users should refrain from using these syringes and transition to alternatives that are not manufactured in China.
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, the recall doesn’t include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
- 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.
