CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report

Micro Introducer Kits under the following labeling recalled

Angiodynamics is recalling AngioDynamics Micro Introducer Kits under the following labeling: AngioDynamics 4F, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCorresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).

Quantity recalledDomestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 boxes,3)260 units/26 boxes,4)880 units/88 boxes,5)60 units/6 boxes,Foreign:10 units/1 box

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-1405-2013
FDA event ID: 65119
Recalling firm: Angiodynamics, Queensbury, NY
Classification: Class II
Status: Terminated
Recall initiated: 30 Apr 2013
FDA classified: 25 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

30 Apr 2013	Recall initiated by company
25 May 2013	Classified by FDA	+25 days
5 Jun 2013	Published in enforcement report	+11 days

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

Reason for recall

AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer Kit, Sterile, Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit, Sterile, Catalog Number: 06597018; and 5) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597019. Product kits are individually wrapped in plastic, 10 units included per box. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

Where it was distributed

USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN

Nationwide Alaska Alabama Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina Nebraska New Jersey New York

Questions about this recall

Is Micro Introducer Kits under the following labeling: AngioDynamics 4F Standard recalled?

Yes. Angiodynamics recalled Micro Introducer Kits under the following labeling: AngioDynamics 4F Standard on 30 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1405-2013.

Why was it recalled?

Which lots are affected?

Corresponding Lot numbers: 1) 588918 (Expiration date 01/2016), 2) 588927 (Expiration date 12/2015), 3) 588915 (Expiration date 01/2016), 4) 588913 (Expiration date 12/2015) and 5) 588930 (Expiration date 01/2016).

Where was it sold?

USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN

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

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