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

Round Drain with Trocar Curved Trocar recalled

Stryker Instruments Div. of Stryker is recalling Round Drain with Trocar 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: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012

Quantity recalled300 boxes (3,000 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-1569-2015
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: Foreign Material
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

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

1/4 in. Round Drain with Trocar 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

Is Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain recalled?

Yes. Stryker Instruments Div. of Stryker recalled Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain on 26 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1569-2015.

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: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012

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 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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