CLASS II Device recall · Reported 20 Jun 2018 · FDA Enforcement Report

Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG recalled

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, distributed in 34 states. The recall was initiated on 10 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPN: H965459011; Lot: G18012001, G18064125

Quantity recalled86 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2197-2018
FDA event ID: 80169
Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
Classification: Class II
Status: Terminated
Recall initiated: 10 May 2018
FDA classified: 14 Jun 2018
Reported: 20 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 May 2018	Recall initiated by company
14 Jun 2018	Classified by FDA	+35 days
20 Jun 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901

Where it was distributed

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. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UPN: H965459011; Lot: G18012001, G18064125

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

37 other products · FDA event 80169

This product is part of a recall event; the main page for the event is Can 5f Single Xcela Picc recalled by Angiodynamics Inc. (Navilyst.

Reported	Class	Recall	Company	Reason	Where
20 Jun 2018	CLASS II	Can 5f Single Xcela Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo Midline 5F DL- MST-45 Kit w/ Two Nitinol Guidewires PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs Tandem 5f Dl Xpp recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	5f Dl Bioflo Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo PICC (NV) 5FSL- Maximal Barrier Nursing Kit w recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Can 5f Dual Xcela Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs Tandem 5f Dl Xcela Picc Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Xcela 5FDL- Maximal Barrier Nursing Kit PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F DL- IR-145 Kit Non-Valved PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo Midline 5F DL- Max Sterile Barrier Drape Kit w recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F DL- MST-70 KIT Non-Valved PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Xcela Pasv 5F SL Ir-145 Nitinol Wire Kit PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F SL- IR-145 Kit Valved with Nitinol GW PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F DL- IR-145 Kit Non-Valved with Nitinol GW PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Xpp Kit recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F SL- MST-70 Kit Valved with Nitinol Guidewire PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Can 5f Dl Bioflo Pasv Picc Nursing Tray recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs - Tandem 5f Dl Bioflo Midline recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs Tandem 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F SL- IR-145 Kit Valved PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Xcela Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo PICC (Valved) 5FDL- Maximal Barrier Nursing Kit PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Tandem 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F SL- IR-145 Kit Non-Valved with Nitinol GW PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs Tandem 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo PICC (Valved) 5FDL- Maximal Barrier Nursing Kit w recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	RS 5F DL XPP recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Bio-Stable 5F DL- MST-70 KIT Non-Valved with Nitinol Guidewire PG recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	BioFlo PICC (NV) 5FDL- Maximal Barrier Nursing Kit w recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs Tandem 5f Dl Bioflo Picc recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states
20 Jun 2018	CLASS II	Rs 5f Dl Bioflo Pasv recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Other	34 states

More recalls from Angiodynamics Inc. (Navilyst Medical Inc.)

All 78

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021Device	CLASS II	Xcela PICC with Pasv Valve Technology/Kit 5 F recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Labeling Errors	NY
28 Apr 2021Device	CLASS II	Smart Port CT-Implantable Port recalled by Angiodynamics Inc. (Navilyst	Angiodynamics Inc. (Navilyst Medical Inc.)	Sterility	Nationwide
28 Apr 2021Device	CLASS II	AngioDynamics Safe Sheath Ultralite recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Sterility	Nationwide
27 Nov 2019Device	CLASS II	Starburst Talon Semi-Flex Electrosurgical Device recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Labeling Errors	5 states
27 Nov 2019Device	CLASS II	Bioflo 8f Single Plastic Non-filled recalled	Angiodynamics Inc. (Navilyst Medical Inc.)	Device Malfunction	Nationwide

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