GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves non-sterile medical devices intended for use in patient care, presenting a direct infection risk. Although no illnesses or injuries have been reported, non-sterile syringes qualify as risk-of-harm products where injury has not yet been reported, per FDA severity guidelines.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling non-sterile GMAX SYR 10ML/LS syringes (Model TS2210S-M) because their piston syringe sizes and configurations fall outside the range of devices cleared under the firm's FDA 510(k) submission.
The affected syringes are single-use, non-sterile devices designed to be used without needles. The recall involves 360,500 units distributed nationwide to locations in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Consumers, healthcare providers, and facilities that have received these syringes should discontinue use immediately. Those with affected units should contact Jiangsu Shenli Medical Production Co., Ltd. for instructions on returns, replacements, or proper disposal.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot Code: LOT: SL21030105
- SL21040104
- SL21070104
- SL21090105
- SL21110104
- SL21 110304
- SL21120104
- SL22030105
- SL22070106
- SL22100205
- SL221202 03
- SL23020204
- SL23080305
- SL23100405
- SL23120405
Distribution
Distributed nationwide across the United States.
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