FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54,204,100 piston syringes nationwide because documentation supporting their sterility claims is insufficient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific issue is insufficient documentation rather than a confirmed contamination or injury, aligning with the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
International Medsurg Connection, Inc. is recalling 54,204,100 units of Piston Syringes, 20 CC L/L (Catalog No. SY35020LL). The recall is being conducted because of insufficient documentation to support the product's sterility claims. These syringes are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
The affected products were distributed nationwide, including in Ohio, Massachusetts, Georgia, Florida, North Carolina, Mississippi, Missouri, Pennsylvania, Indiana, New Jersey, Texas, Kansas, Louisiana, Nebraska, Washington, Alabama, Utah, Alaska, California, Illinois, Minnesota, Maryland, New York, and Michigan. The recall covers numerous lot numbers, with the 'x' in the lot number format representing any release number.
Healthcare facilities and consumers should stop using the affected syringes and contact International Medsurg Connection, Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
- Manufacturer
- International Medsurg Connection, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 54,204,100
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)
- 12-6925-x
- 12-6968-x
- 12-7060-x
- 12-7119-x
- 12-7144-x
- 12-7177-x
- 12-7208-x
- 12-7258-x
- 12-7259-x
- 12-7324-x
- 12-7325-x
- 12-7363-x
- 12-7391-x
- 12-7412-x
- 12-7463-x
- 12-7469-x
- 12-7472-x
- 12-7499-x
- 13-6780-x
- 13-7538-x
Distribution
Part of a larger recall action
This product is one of 59 recalled by International Medsurg Connection, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 59 products in this recall →Related recalls
Same manufacturer · International Medsurg Connection, Inc.
See all →- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
FDA (Devices) · 2017-08-16
- HighFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- ModerateFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
Same hazard · sterility documentation
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