Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected 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 recall of non-sterile syringes manufactured outside approved 510(k) specifications. This is a risk-of-harm product (injection of non-sterile fluid poses infection risk), with no reported injuries mentioned in the source, which per the rubric qualifies as score 3.
Plain-English summary
Jiangsu Shenli Medical Production Co., Ltd. is recalling 754,600 non-sterile syringes (Medline brand, SYR 5ML L/S, Model 83085) distributed in the United States. The recalled devices were manufactured with piston syringe sizes and configurations that fall outside the range previously cleared by the FDA under the firm's 510(k) submission.
The affected syringes were distributed nationwide in California, Florida, Georgia, Illinois, Tennessee, and Virginia. The recalled lot numbers are: 63721010004, 63721100001, 63721110001, 63721120001, 63722010001, 63722020002, 63722030001, 63722040001, 63722050005, 63722070005, 63722080002, 63722090002, 63723070001, 63723090002, 63723100008, 63723110001, and 63723120002.
Because these syringes were manufactured outside approved specifications, they may not function properly or maintain intended sterility, potentially posing risks to users.
The recalled product
- Product
- Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- Hazard
- non-sterile
- specification-violation
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 (17)
- Lot Code: LOT: 63721010004
- 63721100001
- 63721110001
- 63721120001
- 63722010001
- 63722020002
- 63722030001
- 63722040001
- 63722050005
- 63722070005
- 63722080002
- 63722090002
- 63723070001
- 63723090002
- 63723100008
- 63723110001
- 63723120002
Distribution
Distributed nationwide across the United States.
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