Intra Pump Infusion Systems Recalls CRN Crono Syringes Due to Needle Debris
Intra Pump Infusion Systems is recalling CRN Crono Syringes because the needle tips may contain clear debris. The recall affects 25,440 units distributed in the US and Canada.
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, and the hazard involves potential debris on a needle tip without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intra Pump Infusion Systems is recalling 25,440 units of CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle". The recall was initiated because the product has the potential to have clear debris on the tip of the needle.
The affected product is identified by Product Code CRN20 and lot numbers 14N02, 15E01, and 15A02. These syringes were distributed nationwide in the United States, specifically in California, Pennsylvania, Massachusetts, Illinois, Ohio, and New York, as well as internationally to Canada.
Consumers should stop using the affected syringes and contact Intra Pump Infusion Systems for further instructions or a refund.
The recalled product
- Product
- CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
- Manufacturer
- Intra Pump Infusion Systems
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 25,440
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 (4)
- Product Code CRN20
- lot numbers 14N02
- 15E01
- 15A02
Distribution
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