FDAFDA · Food and drugs·Recall number Z-2108-2024
Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Published May 29, 2024 · Recall initiated: April 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Distributor
- U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
- Lot
- Lot Code: LOT: SL21030101,SL21040101,SL21070101,SL21090101,SL21110101,SL21 110301,SL21120101,SL22030101, SL22070101,SL22100201,SL22120201,SL23020201,SL23060301,SL23 080301,SL23100401,SL23100305,SL23120401
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.