Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile s
Summary
The FDA issued a Class II for Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS221 by Jiangsu Shenli Medical Production Co., Ltd.. Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)..
Details
Source
Device Recall
External ID
Z-2112-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Lot/Code Info: Lot Code: LOT: SL22070107,SL22100203,SL23080303,SL23100403,SL23120406
Quantity Affected: 98700
Reason for Recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-05
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Jiangsu Shenli Medical Production Co., Ltd. has 88 FDA actions in our database, including 88 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jiangsu Shenli Medical Production Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jiangsu Shenli Medical Production Co., Ltd. have FDA actions?
Jiangsu Shenli Medical Production Co., Ltd. has 88 FDA actions in our database, including 88 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2112-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29