Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
What this means for you
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 source text describes a procedural delay due to a dimensional specification issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports, Catalog Number 44-025. The recall involves 582 units of the device, which is indicated for long-term access to the central venous system for the administration of fluids, chemotherapy, analgesics, nutritional therapy, and blood products, as well as for blood specimen withdrawal.
The recall was initiated because the snap lock connectors provided within the implantable port kits may not meet dimensional specifications. This defect prevents the catheter from being inserted into the snap lock connector prior to connection to the port chamber, which results in a delay to the implantation procedure.
The affected devices were distributed worldwide, including nationwide in the United States in the states of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, and WI, as well as in Canada. Healthcare providers and patients should contact the recalling firm for further instructions regarding the replacement or return of the affected devices.
The recalled product
- Product
- BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood produc
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 582
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 (1)
- 5488012
Distribution
Part of a larger recall action
This product is one of 5 recalled by Angiodynamics Inc. (Navilyst Medical 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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