FDA recalls GMAX non-sterile syringes sold outside approved specifications
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall. No illnesses or injuries have been reported in the source material. However, the recall involves non-sterile medical syringes distributed without proper FDA clearance for their specific configurations, presenting a potential contamination risk if used for medical purposes. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration is recalling approximately 1.64 million GMAX SYR 3ML/LL non-sterile syringes without needles, manufactured by Jiangsu Shenli Medical Production Co., Ltd. The recalled devices are intended for single use.
The syringes are being recalled because they were manufactured and distributed in sizes and configurations that fall outside the range of devices cleared by the FDA in the firm's 510(k) premarket notification. This means the specific models and configurations being sold were not reviewed and approved by FDA as required.
The recalled syringes were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia, with shipments routed through major ports in Shanghai, Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk. Multiple lot codes are affected, ranging from SL21030101 through SL23120401.
Consumers or healthcare facilities who have received these syringes should discontinue use immediately. Anyone with questions about whether their syringes are affected should contact the manufacturer or consult the FDA's Enforcement Reports for complete lot code information.
The recalled product
- Product
- 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
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- non-sterile
- unapproved-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Lot Code: LOT: SL21030101
- SL21040101
- SL21070101
- SL21090101
- SL21110101
- SL21 110301
- SL21120101
- SL22030101
- SL22070101
- SL22100201
- SL22120201
- SL23020201
- SL23060301
- SL23 080301
- SL23100401
- SL23100305
- SL23120401
Distribution
Distributed nationwide across the United States.
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