Jiangsu Shenli Medical Production Co., Ltd. 2024-05-29 Health serious FDA
Health · FDA · Recall #FDA-Z-2115-2024
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M … Recall
Issued May 29, 2024 · Jiangsu Shenli Medical Production Co., Ltd.
In May 2024, Jiangsu Shenli Medical Production Co., Ltd. recalled the Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
What you should do
- 1 Stop using Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Jiangsu Shenli Medical Production Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Health
- Recall date
- May 29, 2024
- Units affected
- Not reported
- Sold at
- U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then d
- Recall number
- FDA-Z-2115-2024
- Made in
- China
- Issuing agency
- FDA
In context
- Jiangsu Shenli Medical Production Co., Ltd. has 10 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.