FDA Device recall Z-2111-2024
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needle…
- FDA Device
- Class II
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needle… by Jiangsu Shenli Medical Production, citing piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2111-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-05 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Jiangsu Shenli Medical Production |
| Distribution | US |
Product
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Reason
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Identifiers
| code_info | Lot Code: LOT: SL21030104,SL21040103,SL21070103,SL21090104,SL21110103,SL21 110201,SL21110303,SL21120103,SL22030104,SL22…Lot Code: LOT: SL21030104,SL21040103,SL21070103,SL21090104,SL21110103,SL21 110201,SL21110303,SL21120103,SL22030104,SL22070105,SL220801 02,SL22100204,SL22120202,SL23020203,SL23040203,SL23060303,S L23080304,SL23100404,SL23100303,SL23120404 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2111-2024%22
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