The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0501-2020·Announced 2019-11-27

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.

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. 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…
Manufacturer
Angiodynamics Inc. (Navilyst Medical Inc.)
Category
Medical Device — Implantable Port
Hazard
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

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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 →

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