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Z-1566-2015 Class II Terminated

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

FDA device recall Z-1566-2015 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: 1,984 boxes (19,840 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: 1,984 boxes (19,840 each)

Product description

1/4 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: 0215-019-000 and lot numbers: 10095012 10312012 11060012 11186012 11346012 12115012 12349012 13262012 10109012 10321012 11067012 11192012 11356012 12157012 13017012 13277012 10127012 10347012 11088012 11220012 12003012 12193012 13023012 13347012 10189012 10355012 11097012 11230012 12009012 12206012 13044012 14020012 10195012 11011012 11117012 11269012 12026012 12235012 13063012 14030012 10274012 11039012 11136012 11286012 12031012 12290012 13145012 14039012 10285012 11059012 11178012 11335012 12060012 12310012 13254012 14066012

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1566-2015
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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