Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation
Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
- Category
- Medical Device
- Distribution
- Distributed nationwide