AngioDynamics PICC Kits Recalled Due to Defective BD Saline Flush Syringes
AngioDynamics is recalling BioFlo and Xcela PICC Convenience 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any injuries or illnesses, and the specific hazard of the contained syringes is not detailed, placing it in the High category for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AngioDynamics, Inc. is recalling BioFlo PICC and Xcela PICC Convenience Kits. These medical devices are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, and nutrients, blood sampling, and power injection of contrast media.
The recall is necessary because certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes. These specific syringes were recalled by BD Medical on April 16, 2020. The source text does not specify the exact nature of the defect in the BD syringes or the specific health risks associated with them.
A total of 119,723 units were distributed nationwide in the United States. The recall covers numerous specific lot numbers and item numbers. Consumers and healthcare facilities should check their inventory for the affected lot numbers listed in the official recall notice and stop using the affected kits.
The recalled product
- Product
- BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood…
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — PICC Kits
- 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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