Food, drugs, devices › Angiodynamics Inc. (Navilyst Medical Inc.)

Device recall: Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kit

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "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…"

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "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."

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 75322 · Class II · initiated 29 Aug 2016 · status Terminated · terminated 15 Jun 2018

DeviceVoluntary: Firm initiated3 product recordsGlens Falls, NY

Angiodynamics Inc. (Navilyst Medical Inc.) (Glens Falls, NY) initiated this device recall on 29 Aug 2016; FDA lists 3 product records under event 75322, classified Class II.

FDA defines Class II as 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. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 15 Jun 2018. Initiation: voluntary: firm initiated. Angiodynamics Inc. (Navilyst Medical Inc.) has 15 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY.

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…"

Distribution

"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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0708-2017	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 for intravenous therapy, including but…	75 packages (boxes of 5)	Class II	Terminated	14 Dec 2016
Z-0709-2017	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 # H965750355/Catalog No: 5026468 The…	153 packages (boxes of 5)	Class II	Terminated	14 Dec 2016
Z-0710-2017	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…	200 packages (boxes of 5)	Class II	Terminated	14 Dec 2016

Context

91%of 2016 device events are Class II1,232 events that year

3product records in this eventfirm median: 2

15events on this register for the firm

Other enforcement events for Angiodynamics Inc. (Navilyst Medical Inc.)

Initiated	Product (first record)	Type	Class	Records
22 Feb 2021	Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requirin	Device	Class II	2
2 Oct 2019	Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-	Device	Class II	1
18 Sep 2019	BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the ce	Device	Class II	5
17 Apr 2019	AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712	Device	Class II	5
16 Oct 2018	Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711	Device	Class II	2
24 Jul 2018	BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210	Device	Class II	1
10 May 2018	XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124	Device	Class II	38
18 Jan 2018	Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Mo	Device	Class II	1
17 Oct 2017	Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peri	Device	Class II	1
13 Jan 2017	NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005	Device	Class II	1

All 15 events for Angiodynamics Inc. (Navilyst Medical Inc.)

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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…"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.