Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product...

FDA Device Recall #Z-2094-2024 — Class II — April 5, 2024

Recall Summary

Recall Number Z-2094-2024
Classification Class II — Moderate risk
Date Initiated April 5, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Jiangsu Shenli Medical Production Co., Ltd.
Location Changzhou
Product Type Devices
Quantity 17280

Product Description

Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No

Reason for Recall

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Distribution Pattern

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 / Code Information

Lot Code: LOT: 63721010004,63721040002,63721050002,63721080 003,63721100001,63721100003,63721110001, 63722010001,63722030001,63722050001,63722100 003,63723030001,63723060005,63723070001

Other Recalls from Jiangsu Shenli Medical Production Co....

Recall # Classification Product Date
Z-2124-2024 Class II Brand Name: GMAX Product Name: SYR 5ML/LL syri... Apr 5, 2024
Z-2063-2024 Class II Brand Name: MEDLINE Product Name: SYR 10ML L/L... Apr 5, 2024
Z-2062-2024 Class II Brand Name: MEDLINE Product Name: SYR 10ML L/L... Apr 5, 2024
Z-2074-2024 Class II Brand Name: MEDLINE Product Name: SYR 10ML L/L... Apr 5, 2024
Z-2115-2024 Class II Brand Name: GMAX Product Name: SYR 35ML/LL syr... Apr 5, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.