Home / Recalls / Stryker Instruments Div. Of Stryker Corporation / Z-1562-2015

Z-1562-2015 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-1562-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Mar 26, 2015 and is designated Class II. Reason for recall: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging The recall status is terminated (terminated Dec 31, 2015). Affected quantity: 2,711 boxes (27,110 each).

Recall details

Product Type: Devices
Report Date: May 13, 2015
Initiation Date: Mar 26, 2015
Termination Date: Dec 31, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,711 boxes (27,110 each)

Product description

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 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.

Reason for recall

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

Distribution pattern

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

Code information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1562-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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