Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates
Navilyst Medical is recalling Xcela Power Injectable 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: This is a Class II recall involving a minor labeling error (incorrect expiration date) on a component of the kit, which fits the rubric for moderate severity.
Plain-English summary
Navilyst Medical Inc. is recalling 75 packages of Xcela Power Injectable PICC 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 kits are Tandem Pack Convenience Kits that include an NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including the administration of fluids, medications, and nutrients, blood sampling, and power injection of contrast media.
The affected lots are 505722 and 5056512. The products were distributed nationwide, including in 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. Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line Kits
- 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 (2)
- Batch/Lot: 505722
- 5056512
Distribution
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 →Related recalls
Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)
See all →- ModerateXcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAngiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates
FDA (Devices) · 2018-12-19
- HighNavilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology
FDA (Devices) · 2016-06-22
- HighNavilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Defects
FDA (Devices) · 2014-10-15
- ModerateNavilyst Medical Recalls BioFlo PICC Kits Due to Syringe Seal Issues
FDA (Devices) · 2014-10-15
- HighNavilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk
FDA (Devices) · 2016-06-22
- HighNavilyst Medical Recalls Xcela Hybrid PICC Catheters with Valve Technology
FDA (Devices) · 2016-06-22