60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
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 medical device recall with no reported illnesses or injuries. The devices were manufactured outside the scope of the firm's 510(k) clearance. Medical syringes are risk-of-harm products, warranting High severity for this regulatory non-compliance.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 60 mL (cc) Luer Lock piston syringes sold under the Wolf Medical brand (Model SYR60L). The syringes are single-use devices without needles.
The syringes are being recalled because their sizes and configurations exceed the range of devices cleared under the firm's FDA 510(k) application. This regulatory deviation means the products do not comply with the specifications that were validated during FDA clearance review.
The affected syringes have been distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The following lot codes are involved: 20200204, 20200301, 20201201, 20210104, 20210301, 20211112, 20220414, 20220614, 20221015, 20231006, and 20240301.
Customers who have received these recalled syringes should discontinue use and contact the manufacturer for guidance on replacement or return.
The recalled product
- Product
- Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L 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
- manufacturing-deviation
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 (10)
- Lot Code: LOT: 20200204
- 20200301
- 20201201
- 20210104
- 20210301
- 20211112
- 20220414
- 20220614
- 20221015
- 20231006 20240301
Distribution
Distributed nationwide across the United States.
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