Device recall: XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124

Class II FDA enforcement event 80169. Recall start date: 10 May 2018. Status in the FDA record: Terminated. Termination date: 13 May 2020.

Reason for recall, in the words of FDA

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Class II, in the words of FDA

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

Angiodynamics Inc. (Navilyst Medical Inc.) started this device recall on 10 May 2018. The firm address in the FDA record is in Glens Falls, NY. FDA put the recall in Class II. FDA event 80169 has 38 product records. The first FDA enforcement report date is 20 Jun 2018. The record gives the status Terminated, with the termination date 13 May 2020.

FDA enforcement report The 38 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV.…

Recalling firm

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

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

38 product records in the event.

FDA event 80169: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2188-2018	XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124	7 boxes	Class II	Terminated	20 Jun 2018
Z-2189-2018	Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818	50 boxes	Class II	Terminated	20 Jun 2018
Z-2190-2018	Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871	200 boxes	Class II	Terminated	20 Jun 2018
Z-2191-2018	Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872	20 boxes	Class II	Terminated	20 Jun 2018
Z-2192-2018	Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882	17 boxes	Class II	Terminated	20 Jun 2018
Z-2193-2018	Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886	58 boxes	Class II	Terminated	20 Jun 2018
Z-2194-2018	Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887	246 boxes	Class II	Terminated	20 Jun 2018
Z-2195-2018	Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892	11 boxes	Class II	Terminated	20 Jun 2018
Z-2196-2018	Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895	298 boxes	Class II	Terminated	20 Jun 2018
Z-2197-2018	Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901	86 boxes	Class II	Terminated	20 Jun 2018
Z-2198-2018	BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490	190 boxes	Class II	Terminated	20 Jun 2018
Z-2199-2018	BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810	23 boxes	Class II	Terminated	20 Jun 2018
Z-2200-2018	RS TANDEM 5F DL XPP, Catalog Number 60M019881	7	Class II	Terminated	20 Jun 2018
Z-2201-2018	RS 5F DL XPP, Catalog Number 60M030393	7 boxes	Class II	Terminated	20 Jun 2018
Z-2202-2018	RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472	3 boxes	Class II	Terminated	20 Jun 2018
Z-2203-2018	RS 5F DL BIOFLO PICC, Catalog Number 60M071831	12 boxes	Class II	Terminated	20 Jun 2018
Z-2204-2018	RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196	2 boxes	Class II	Terminated	20 Jun 2018
Z-2205-2018	RS 5F DL BIOFLO PASV, Catalog Number 60M132324	2 boxes	Class II	Terminated	20 Jun 2018
Z-2206-2018	TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567	1 box	Class II	Terminated	20 Jun 2018
Z-2207-2018	5F DL BIOFLO PASV, Catalog Number 60M141006	36 boxes	Class II	Terminated	20 Jun 2018
Z-2208-2018	RS 5F DL BIOFLO PASV, Catalog Number 60M150373	7 boxes	Class II	Terminated	20 Jun 2018
Z-2209-2018	RS 5F DL BIOFLO PASV, Catalog Number 60M161567	2 boxes	Class II	Terminated	20 Jun 2018
Z-2210-2018	5F DL BIOFLO PICC, Catalog Number 60M180592	12 boxes	Class II	Terminated	20 Jun 2018
Z-2211-2018	RS 5F DL BIOFLO PASV, Catalog Number 60M181578	11 boxes	Class II	Terminated	20 Jun 2018
Z-2212-2018	RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582	13 boxes	Class II	Terminated	20 Jun 2018
Z-2213-2018	RS 5F DL XPP KIT, Catalog Number 60M183104	5 boxes	Class II	Terminated	20 Jun 2018
Z-2214-2018	RS 5F DL BIOFLO PASV, Catalog Number 60M183481	104 boxes	Class II	Terminated	20 Jun 2018
Z-2215-2018	RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242	20 boxes	Class II	Terminated	20 Jun 2018
Z-2216-2018	RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097	15 boxes	Class II	Terminated	20 Jun 2018
Z-2217-2018	CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936	2 boxes	Class II	Terminated	20 Jun 2018
Z-2218-2018	CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531	17 boxes	Class II	Terminated	20 Jun 2018
Z-2219-2018	CAN 5F DUAL XCELA PICC, Catalog Number 60M701532	27 boxes	Class II	Terminated	20 Jun 2018
Z-2220-2018	Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003	99 boxes	Class II	Terminated	20 Jun 2018
Z-2221-2018	BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019	132 boxes	Class II	Terminated	20 Jun 2018
Z-2222-2018	BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032	3 boxes	Class II	Terminated	20 Jun 2018
Z-2223-2018	BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033	81 boxes	Class II	Terminated	20 Jun 2018
Z-2224-2018	BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038	79 boxes	Class II	Terminated	20 Jun 2018
Z-2225-2018	RS 5F DL XCELA PICC, Catalog Number 60M122272	6 boxes	Class II	Terminated	20 Jun 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 38Median of the firm: 2
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of 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
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
28 Nov 2016	Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catal	Device	Class II	13

Angiodynamics Inc. (Navilyst Medical Inc.): all 15 events

Official channels

FDA enforcement report Z-2188-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 80169. https://recallregister.com/fda/ii/80169/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV.…
What quantity of product is in FDA event 80169?: The event has 38 product records. The first record gives this quantity: 7 boxes
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.