CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report

Edwards Lifesciences EZ Glide Aortic Cannula, 24F x, resterilized recalled

SPS Sterilization is recalling Edwards Lifesciences EZ Glide Aortic Cannula, 24F x, resterilized, distributed in 8 states. The recall was initiated on 7 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Quantity recalled6 units total

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-3028-2018
FDA event ID: 80317
Recalling firm: SPS Sterilization, Nixa, MO
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2018
FDA classified: 13 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

7 Mar 2018	Recall initiated by company
13 Sep 2018	Classified by FDA	+190 days
19 Sep 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

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.

Where it was distributed

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

Arizona California Florida Ohio Pennsylvania Texas Virginia West Virginia

Questions about this recall

Why was it recalled?

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Which lots are affected?

Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37

Where was it sold?

US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

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

14 other products · FDA event 80317

This product is part of a recall event; the main page for the event is Edwards Lifesciences Avid Dual Stage Venous Drainage recalled.

Reported	Class	Recall	Company	Reason	Where
19 Sep 2018	CLASS II	Edwards Lifesciences Avid Dual Stage Venous Drainage recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Thin-Flex Single Stage Venous Drainage recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent Endoprosthesis Tracheobronchial recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Thin-Flex Single Stage Venous Drainage recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent Enteral Endoprosthesis recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent Endoprosthesis Tracheobronchial recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent RP Endoprosthesis recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Vascular Solutions Venture Rx Catheter, 6F, resterilized recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent Endoprosthesis Tracheobronchial recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Femoral Venous Cannula, resterilized recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Boston Scientific Wallstent RP Endoprosthesis recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Optisite Arterial Perfusion Cannula recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Aortic Perfusion Cannula, 24F, resterilized recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018	CLASS II	Edwards Lifesciences Femoral Venous Cannula, 20F, resterilized recalled	SPS Sterilization	Sterility	8 states

More recalls from SPS Sterilization

All 15

Reported	Class	Recall	Company	Reason	Where
19 Sep 2018Device	CLASS II	Edwards Lifesciences Femoral Venous Cannula, 20F, resterilized recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018Device	CLASS II	Edwards Lifesciences Aortic Perfusion Cannula, 24F, resterilized recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018Device	CLASS II	Edwards Lifesciences Optisite Arterial Perfusion Cannula recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018Device	CLASS II	Boston Scientific Wallstent RP Endoprosthesis recalled	SPS Sterilization	Sterility	8 states
19 Sep 2018Device	CLASS II	Edwards Lifesciences Femoral Venous Cannula, resterilized recalled	SPS Sterilization	Sterility	8 states

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide