Non-sterile Medline piston syringes recalled for exceeding FDA scope
Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units 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: FDA Class II device distributed in sizes and configurations outside the company's approved 510(k) scope. Although no illnesses or injuries have been reported, the regulatory non-compliance represents a potential risk of harm from non-validated device configurations.
Plain-English summary
Medline, through its manufacturer Jiangsu Shenli Medical Production Co., Ltd., has recalled SYR 20ML L/L non-sterile piston syringes without needles (Model 83088). The recall involves approximately 13.6 million units that were distributed nationwide.
The syringes were manufactured in sizes and configurations outside the range covered by the company's FDA 510(k) clearance. This regulatory non-compliance means the devices were produced and distributed without proper FDA approval for those specific configurations.
The affected products were distributed to CA, FL, GA, IL, TN, and VA, with shipments arriving through major ports including Chicago, Los Angeles, Long Beach, Miami, Savannah, Nashville, and Norfolk.
Consumers and healthcare providers who have these syringes should contact Medline or the FDA for guidance on return or proper disposal.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Category
- Medical Device
- Hazard
- regulatory-non-compliance
- out-of-cleared-scope
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 (20)
- Lot Code: LOT: 63720120007
- 63721010002
- 63721010003
- 63721010004
- 63721040002
- 63721050002
- 63721060001
- 63721070001
- 63721070003
- 63721070004
- 63721070006
- 63721080001
- 63721080002
- 63721080003
- 63721080004
- 63721080005
- 63721090001
- 63721090002
- 63721090004
- 63721100001
Distribution
Distributed nationwide across the United States.
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