Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Filled Non-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. The hazard involves a procedural delay due to dimensional specifications rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 582 units of BIOFLO 8F Single Plastic Filled; Non-Valved ports (UPN H965440140, Cat. No. 44-014). These medical devices are used 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 is due to a defect where the snap lock connectors provided within the implantable port kits may not meet dimensional specifications. This issue 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 products 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. The specific codes associated with the recall are 5487932, 5487933, and 5488008. Healthcare providers and patients should contact the recalling firm for further instructions regarding the affected devices.
The recalled product
- Product
- BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - 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 products
- 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 (3)
- 5487932
- 5487933
- 5488008
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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