CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report

Trocar with Single Drain Curved Trocar recalled

Stryker Instruments Div. of Stryker is recalling Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain, distributed nationwide in the US. The recall was initiated on 26 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 0215-018-000 and lot numbers: 10076012 10284012 11108012 11280012 12110012 12334012 13158012 14020012 10095012 10292012 11117012 11298012 12131012 12338012 13182012 14050012 10103012 10295012 11125012 11305012 12143012 12339012 13191012 14056012 10112012 10307012 11136012 11308012 12153012 12348012 13220012 14059012 10125012 10319012 11143012 11339012 12158012 12352012 13227012 14076012 10133012 10335012 11145012 11343012 12160012 13011012 13238012 14083012 10137012 10342012 11146012 11356012 12164012 13035012 13239012 14147012 10160012 10356012 11157012 12012012 12181012 13050012 13261012 14165012 10175012 11010012 11161012 12019012 12188012 13059012 13262012 14169012 10188012 11014012 11187012 12030012 12242012 13078012 13274012 14174012 10205012 11026012 11204012 12051012 12255012 13091012 13281012 14189012 10222012 11032012 11221012 12053012 12262012 13099012 13298012 14190012 10228012 11043012 11230012 12055012 12277012 13106012 13323012 14231012 10237012 11053012 11249012 12061012 12292012 13113012 13324012 14233012 10252012 11069012 11251012 12065012 12303012 13138012 13340022 14245012 10266012 11088012 11265012 12081012 12313012 13144012 13351012 14280012 10273012 11103012 11269012 12091012 12317012 13155012 14017012 14344012

Quantity recalled6,424 boxes (64,240 each)

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-1564-2015
FDA event ID: 70841
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2015
FDA classified: 1 May 2015
Reported: 13 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

26 Mar 2015	Recall initiated by company
1 May 2015	Classified by FDA	+36 days
13 May 2015	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

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

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

1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Where it was distributed

Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Which lots are affected?

Part Number: 0215-018-000 and lot numbers: 10076012 10284012 11108012 11280012 12110012 12334012 13158012 14020012 10095012 10292012 11117012 11298012 12131012 12338012 13182012 14050012 10103012 10295012 11125012 11305012 12143012 12339012 13191012 14056012 10112012 10307012 11136012 11308012 12153012 12348012 13220012 14059012 10125012 10319012 11143012 11339012 12158012 12352012 13227012 14076012 10133012 10335012 11145012 11343012 12160012 13011012 13238012 14083012 10137012 10342012 11146012 11356012 12164012 13035012 13239012 14147012 10160012 10356012 11157012 12012012 12181012 13050012 13261012 14165012 10175012 11010012 11161012 12019012 12188012 13059012 13262012 14169012 10188012 11014012 11187012 12030012 12242012 13078012 13274012 14174012 10205012 11026012 11204012 12051012 12255012 13091012 13281012 14189012 10222012 11032012 11221012 12053012 12262012 13099012 13298012 14190012 10228012 11043012 11230012 12055012 12277012 13106012 13323012 14231012 10237012 11053012 11249012 12061012 12292012 13113012 13324012 14233012 10252012 11069012 11251012 12065012 12303012 13138012 13340022 14245012 10266012 11088012 11265012 12081012 12313012 13144012 13351012 14280012 10273012 11103012 11269012 12091012 12317012 13155012 14017012 14344012

Where was it sold?

Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.

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

11 other products · FDA event 70841

This product is part of a recall event; the main page for the event is Double Trocar with Wound Drain Curved Trocar recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2015	CLASS II	Double Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Double Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Round Drain with Trocar Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Trocar with Single Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Trocar with Single Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Curved Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Curved Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Ambulating Bulb Ambulating Bulb recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Double Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Curved Trocar with Wound Drain Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide
13 May 2015	CLASS II	Round Drain with Trocar Curved Trocar recalled	Stryker Instruments Div. of Stryker	Sterility	Nationwide

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6 May 2020Device	CLASS II	Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of	Stryker Instruments Div. of Stryker	Other	MI

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