Medline Syringes Recalled for Out-of-Specification Design Configuration
Medline 10ml syringes in lots 63721060001, 63721110001, 63722120002, and 63723070001 are recalled because their sizes and configurations exceed FDA-approved specifications. No injuries reported.
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: This FDA Class II recall involves medical devices operating outside their approved specifications—a risk-of-harm situation. No injuries or illnesses have been reported.
Plain-English summary
Medline SYR 10ML L/L YELLOW LIDO syringes (Model 91854, non-sterile, without needles) manufactured by Jiangsu Shenli Medical Production Co., Ltd. are being recalled.
The recalled syringes have sizes and configurations that fall outside the range of devices cleared by the FDA under the firm's 510(k) authorization. This means they do not meet the specifications for which they were approved for distribution and use.
Approximately 23,800 units were distributed nationwide, including to California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Customers and healthcare facilities that have received these products should stop using them immediately and contact Jiangsu Shenli Medical Production Co., Ltd. for instructions on return or replacement. No injuries or illnesses related to these syringes have been reported.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- improper-specification
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 (4)
- Lot Code: LOT: 63721060001
- 63721110001
- 63722120002
- 63723070 001
Distribution
Distributed nationwide across the United States.
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