AngioDynamics PICC Kits Recalled Due to Defective Saline Flush Syringes
AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.
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, which typically indicates a temporary or medically reversible adverse health consequence. As no specific injuries or illnesses are reported in the source text and the hazard is derived from a component recall, it fits the Moderate criteria.
Plain-English summary
AngioDynamics, Inc. is recalling certain BioFlo Midline Convenience Kits (PICC Kits) because they contain BD PosiFlush SF Saline Flush Syringes. These syringes were independently recalled by BD Medical on April 16, 2020.
The recall involves 119,723 units of the kits, which were distributed nationwide in the United States. The kits are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads, in the vasculature.
Healthcare facilities and consumers should stop using the affected kits and contact AngioDynamics for further instructions or a replacement. The specific reason for the BD Medical recall of the syringes is not detailed in this notice, but the presence of the recalled component necessitates the removal of the kits from distribution.
The recalled product
- Product
- BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721…
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 119,723
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)
- therefore
- removed from recall notification.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Angiodynamics, 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.
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