FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
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 Class II recall with no reported illnesses or injuries. The hazard involves out-of-specification piston syringes that represent a potential product-defect risk but injury has not yet been reported, fitting the rubric criterion for High severity.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 1,248,000 units of GMAX SYR 5ML/LL non-sterile syringes (Model TS2205L-M) distributed in the United States. The affected lot codes are SL21030101, SL21040101, SL21070101, SL21090101, SL21110101, SL21110301, SL21120101, SL22030101, SL22070101, SL22100201, SL22120201, SL23020201, SL23060301, SL23080301, SL23100401, SL23100305, and SL23120401.
The syringes are being recalled because their piston sizes and configurations fall outside the range of devices that were cleared by FDA under the firm's 510(k) premarket notification. This means the devices do not comply with the specifications reviewed and approved by FDA.
These non-sterile syringes for single use were distributed nationwide, with shipments to California, Florida, Georgia, Illinois, Tennessee, and Virginia. If you have received or used syringes from the affected lot codes, discontinue use and contact the manufacturer for instructions.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- device-defect
- specification-noncompliance
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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