Fresenius Kabi Recalls HEPFLUSH-10 Heparin Lock Flush Solution Due to pH Failure
Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a specification failure (pH) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Fresenius Kabi USA, LLC is recalling HEPFLUSH-10 (Heparin Lock Flush Solution, USP) 100 USP units per 10 mL, Single Dose Vial. The recall involves Lot 6005501 with an expiration date of 1/2016. A total of 69,725 units were distributed nationwide.
The recall was initiated because the affected lot failed to meet pH specifications. The product is classified as a Class II recall by the U.S. Food and Drug Administration.
Healthcare providers and facilities should check their inventory for this specific lot number and expiration date. If found, the product should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
- Manufacturer
- Fresenius Kabi USA, LLC
- Hazard
- Affected units
- 69,725
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)
- Lot 6005501
- Exp. Date 1/2016
Distribution
Distributed nationwide across the United States.
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