Medical syringes recalled due to manufacturing specification deviation
Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes 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: Classified as FDA Class II. Syringes manufactured outside their approved 510(k) specifications pose potential safety and functionality risks, as deviations from tested designs can introduce unpredictable hazards in medical devices.
Plain-English summary
Medline is recalling approximately 9.05 million 10mL non-sterile syringes without needles for single use, manufactured by Jiangsu Shenli Medical Production Co., Ltd. The devices were removed from distribution because their sizes and configurations fall outside the range approved by the FDA in the manufacturer's 510(k) submission.
The recalled syringes, model 91881, were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia through various U.S. ports and warehouses. Specific lot codes are available through the FDA and Medline.
Consumers and healthcare facilities that have received these syringes should stop using them and contact their supplier or Medline for instructions on handling the recalled products.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 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 (20)
- Lot Code: LOT: 63721010001
- 63721010003
- 63721040002
- 63721050 002
- 63721060001
- 63721070001
- 63721070002
- 63721070003
- 63721070004
- 63721070006
- 63721080 001
- 63721080002
- 63721080003
- 63721080004
- 63721080005
- 63721090001
- 63721090003
- 63721090 004
- 63721090005
- 63721100001
Distribution
Distributed nationwide across the United States.
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