Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic 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. The hazard involves a procedural delay due to dimensional specifications rather than direct physical injury or contamination, fitting the criteria for a moderate severity recall without reported injuries.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 582 units of BIOFLO 8F Single Plastic Non-Filled Valved ports (UPN H965440210, Cat. No. 44-021). These devices are used for long-term access to the central venous system for administering fluids, chemotherapy, 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 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. Healthcare providers should contact the recalling firm for instructions on how to handle the affected devices.
The recalled product
- Product
- BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - 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 (1)
- 5478023
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.
See all 5 products in this recall →Related recalls
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