MEDLINE Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
MEDLINE has recalled 42,000 non-sterile syringes (Model 91847) because their sizes and configurations exceed FDA-approved specifications. The products were distributed nationwide.
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 is an FDA Class II recall of medical devices whose specifications deviate from FDA-cleared designs. While no illnesses or injuries have been reported, the regulatory non-compliance with approved device specifications presents a potential risk to users.
Plain-English summary
MEDLINE has issued a recall of non-sterile syringes under the product name SYR 10ML L/L BLUE LIDO (Model/Catalog Number 91847). A total of 42,000 units are affected by this recall.
The devices are being recalled because their sizes and configurations fall outside the range of devices cleared by the FDA under the manufacturer's 510(k) submission. This regulatory non-compliance means the products do not match the specifications that were previously approved by the FDA.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through major U.S. ports and distribution centers including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare facilities with affected products should stop using them immediately and contact Jiangsu Shenli Medical Production Co., Ltd., the manufacturer, for further instructions regarding returns or replacements.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device — Syringes
- Hazard
- out-of-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 (6)
- Lot Code: LOT: 63721010001
- 63721100001
- 63722050001
- 63722060 001
- 63722070002
- 63723010001
Distribution
Distributed nationwide across the United States.
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