Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2016 - (Recall #: Z-0710-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

Product Classification:

Class II

Date Initiated: August 29, 2016

Date Posted: December 14, 2016

Recall Number: Z-0710-2017

Event ID: 75322

Reason for Recall:

Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.

Status: Terminated

Product Quantity: 200 packages (boxes of 5)

Code Information:

Batch/Lot: 5018263, 5020646, 5046472, 5051539

Distribution Pattern:

Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated