FDAClass IIMay 13, 2015

3/16 in. Trocar with Single Drain Curved Trocar with recall: Sterility Concern

3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal…

Why was 3/16 in. Trocar with Single Drain Curved Trocar with recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012

Product
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
2,711 boxes (27,110 each)
Distribution
Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Recall date
May 13, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls