GMAX SYR 5ML syringes recalled for unapproved piston configurations
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.
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 of medical device configurations not cleared under the firm's 510(k) application. Unvalidated syringe configurations represent a risk of harm through potential performance or safety issues, even though no illnesses or injuries have been reported.
Plain-English summary
GMAX SYR 5ML/LL syringes (Model TS2205S-M) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled. These are non-sterile, single-use syringes without needles.
The reason for the recall is that the piston syringes were manufactured in sizes and configurations that fall outside the range of devices cleared under the firm's FDA 510(k) application. These specific configurations were not submitted for or approved by the FDA before manufacturing and distribution.
The recall affects 60,000 units that were distributed nationwide to customers in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The affected lot codes are SL22070103, SL22030103, SL21120111, SL21090103, and SL21030103.
The recalled product
- Product
- Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-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
- regulatory-non-compliance
- unapproved-configuration
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 (1)
- Lot Code: LOT: SL22070103 SL22030103 SL21120111 SL21090103 SL21030103
Distribution
Distributed nationwide across the United States.
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