CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report

Reinforced Dual Lumen Cannula recalled by OriGen Biomedical

OriGen Biomedical is recalling Reinforced Dual Lumen Cannula, distributed nationwide in the US. The recall was initiated on 21 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00816203022059, lot N18687-1

Quantity recalled106

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-0102-2019
FDA event ID: 81098
Recalling firm: OriGen Biomedical, Austin, TX
Classification: Class II
Status: Terminated
Recall initiated: 21 Aug 2018
FDA classified: 12 Oct 2018
Reported: 24 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Aug 2018	Recall initiated by company
12 Oct 2018	Classified by FDA	+52 days
24 Oct 2018	Published in enforcement report	+12 days

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

Reason for recall

The catheter failed the endotoxin testing.

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

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

Where it was distributed

US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Louisiana Massachusetts Maryland Michigan Missouri North Carolina New Mexico New York Ohio Oregon Pennsylvania Rhode Island

Questions about this recall

Is Reinforced Dual Lumen Cannula recalled?

Yes. OriGen Biomedical recalled Reinforced Dual Lumen Cannula on 21 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0102-2019.

Why was it recalled?

The catheter failed the endotoxin testing.

Which lots are affected?

UDI: 00816203022059, lot N18687-1

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 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 OriGen Biomedical

All 19

Reported	Class	Recall	Company	Reason	Where
21 Feb 2024Device	CLASS II	Accessory Sets Syringes: syringe with a female luer recalled	OriGen Biomedical	Sterility	11 states
21 Apr 2021Device	CLASS III	Evolve Cell Culture, part numbers: EV1000N recalled by OriGen Biomedical	OriGen Biomedical	Labeling Errors	19 states
11 Nov 2020Device	CLASS II	3/8" FloPump, (Sterile) recalled by OriGen Biomedical	OriGen Biomedical	Sterility	TX
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states
12 Jun 2019Device	CLASS I	ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled	OriGen Biomedical	Lead & Heavy Metals	33 states

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