Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2015 - (Recall #: Z-1566-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 26, 2015

Date Posted: May 13, 2015

Recall Number: Z-1566-2015

Event ID: 70841

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,984 boxes (19,840 each)

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated