Recall Z-2106-2024— Jiangsu Shenli Medical Production Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Jiangsu Shenli Medical Production Co., Ltd., initiated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L 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)..
- Recalling firm
- Jiangsu Shenli Medical Production Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-05
- Firm location
- Changzhou, China
Product description
Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Data sourced from openFDA. This site is unofficial and independent of the FDA.