Skip to content
Recall Observatory FDA recall evidence

Device product

3/16 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.

Z-1568-2015

March 26, 2015

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 70841
Status
Terminated
Classification
Class II
Quantity
648 boxes (6,480 each)
Official record key
device-enforcement:Z-1568-2015

Official wording

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

Code information: Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 14044012 10104012 10263012 11012012 11185012 12053012 12237012 13126012 14147012 10147012 10279012 11055012 11216012 12082012 12318012 13163012 14153012 10153012 10309012 11110012 11252012 12116012 12331012 13211012

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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