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Jiangsu Shenli Medical Production Co., Ltd. Recall: Brand Name: GMAX Product Name: SYR 35M

Jiangsu Shenli Medical Production Co., Ltd. Recall: Brand Name: GMAX Product Name: SYR 35M is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Jiangsu Shenli Medical Production Co., Ltd.; Product: Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product De

Recalling firmJiangsu Shenli Medical Production Co., Ltd.
ProductBrand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Reason for recallPiston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionU.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
Recall initiated20240405
Recall numberZ-2115-2024
Categorydevice
CountryChina

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