Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0709-2017·Announced 2016-12-14

BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the 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 moderate severity involving minor labeling errors.

Plain-English summary

Navilyst Medical Inc. is recalling specific lots of BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kits. The recall is due to a labeling error where the sterile package gloves included in the kits contain an incorrect expiration date.

Medline Industries, Inc., which supplies the sterile gloves to Navilyst, identified that specific lots of gloves (Part Numbers MSG1075/MSG3075) were affected. Navilyst confirmed that these affected gloves were included in a limited number of kits. The recall involves 153 packages (boxes of 5) distributed nationwide to states including AZ, CA, FL, GA, HI, IL, IN, KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA, and the District of Columbia.

Healthcare facilities and consumers should check their inventory for the specific lot numbers and catalog numbers listed in the recall notice. If the affected kits are found, they should be removed from use and returned to the manufacturer or supplier according to the recall instructions.

The recalled product

Product: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #…
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — PICC Line Accessories
Hazard: mis-labeling

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 (6)

Batch/Lot: 1) 5018265
2) 5024787
3) 5021872
4) 5020644
5) 5026458
6) 5026468

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 →

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

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Same hazard · mis labeling