GMAX SYR 60ML/LL Blue Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall for syringes manufactured to specifications outside the FDA-cleared range. Although no injuries or illnesses have been reported, syringes with unapproved specifications represent a risk-of-harm product where the device may not function as validated.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling GMAX SYR 60ML/LL blue non-sterile syringes without needles. The syringes are being recalled because their piston syringe sizes and configurations fall outside the range of devices cleared by the FDA under the firm's 510(k) submission.
The recalled product has Model number TS2260LB-M. Approximately 116,160 units were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. Shipment occurred through U.S. ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
The affected lot codes are SL22080108, SL23020210, and SL23040209. Individuals with access to affected syringes should contact their healthcare provider or medical supplier for further instructions.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringe
- Affected units
- 116,160
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 (3)
- Lot Code: LOT: SL22080108
- SL23020210
- SL23040209
Distribution
Part of a larger recall action
This product is one of 87 recalled by Jiangsu Shenli Medical Production Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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