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U.S. Department of Health and Human Services

Class 2 Device Recall GMAX

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  Class 2 Device Recall GMAX see related information
Date Initiated by Firm April 05, 2024
Date Posted May 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-2113-2024
Recall Event ID 94520
Product Classification Syringe, piston - Product Code FMF
Product Brand Name: GMAX
Product Name: SYR 20ML/LL syringe
Model/Catalog Number: TS2220L-M
Product Description: NON-Sterile syringes without needles for single use
Component: No
Code Information Lot Code: LOT: SL21030106,SL21040105,SL21070105,SL21090106,SL21110105,SL21 110202,SL21120105,SL22030106,SL22070109,SL22080103,SL221002 07,SL22120205,SL23020205,SL23040205,SL23060304,SL23080307, SL23100407,SL23100301,SL23120407
Recalling Firm/
Manufacturer		 Jiangsu Shenli Medical Production Co., Ltd.
No. 20 Changzheng Road
Zhengluzhen Wujin
Changzhou China
For Additional Information Contact Liqun Yang
+8651988731071
Manufacturer Reason
for Recall		 Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
FDA Determined
Cause 2		 No Marketing Application
Action On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email shenli@syringechina.com or telephone number 0086-519-88731071
Quantity in Commerce 2491600
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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