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

Edwards Lifesciences Thin-Flex Single Stage Venous Drainage recalled

SPS Sterilization is recalling Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (16"), 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 TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

Quantity recalled5 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-3030-2018
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 Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), 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

Stores named: Walmart

Questions about this recall

Is Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (16") recalled?

Yes. SPS Sterilization recalled Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (16") on 7 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-3030-2018.

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 TF034L-R; Lot Number 59739865; Serial Numbers 18304192017-12, 18304192017-13, 18304192017-14, 18304192017-15, 18304192017-16

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 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.

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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