The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0710-2017·Announced 2016-12-14

BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

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, but the specific defect is a minor labeling error (incorrect expiration date) on the included gloves, which fits the criteria for a moderate severity voluntary precautionary recall without reported injuries.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 200 packages of BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kits. The recall is due to a labeling error where specific lots of sterile package gloves supplied by Medline Industries, Inc. contain an incorrect expiration date.

The affected gloves, identified by Medline Part Numbers MSG1075 and MSG3075, were included in a limited number of the nursing kits. The kits are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, nutrients, blood sampling, and power injection of contrast media.

The recall covers nationwide distribution, including Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Dakota, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington, and the District of Columbia. Affected lot numbers are 5018263, 5020646, 5046472, and 5051539. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact the manufacturer for instructions on returning the product.

The recalled product

Product
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
Manufacturer
Angiodynamics Inc. (Navilyst Medical Inc.)
Category
Medical Device — PICC Line / IV Therapy
Hazard

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 (4)

  • Batch/Lot: 5018263
  • 5020646
  • 5046472
  • 5051539

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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