CarePoint 60 mL Syringes Recalled Due to Green Substance on Plunger
Allison Medical recalls CarePoint 60 mL syringes due to green substance found on plungers. While the substance is nontoxic, its potential interaction with medications is unknown.
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: This is a FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—the substance is nontoxic, but its potential drug-interaction effects are unknown. Per the rubric, recalls with theoretical hazards and no reported illness are typically scored as 2; this low-risk contamination with unknown interaction potential meets the criteria for Moderate.
Plain-English summary
Allison Medical, Inc. is recalling CarePoint 60 mL Syringe Without Needle (REF: 04-7560) due to a green substance found on the plunger of affected units.
The substance has been determined to be nontoxic; however, its potential effects on drug potency or interaction with medications are unknown. This creates uncertainty regarding the safety of injections using affected syringes.
The recall affects 2,004 boxes of the product distributed in the United States (Iowa, Louisiana, Mississippi, Florida, and Puerto Rico) and Barbados. The affected lot is REF/Lot 04-7560/80522.
Consumers who have received or are using affected syringes should discontinue use and contact Allison Medical, Inc. for instructions on replacement or disposal. Healthcare providers should quarantine affected units.
The recalled product
- Product
- CarePoint 60 mL Syringe Without Needle, REF: 04-7560
- Manufacturer
- Allison Medical, Inc.
- Affected units
- 2,004
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 (2)
- UDI-DI: 00786227756059
- REF/Lot: 04-7560/ 80522
Distribution
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