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Recall Observatory FDA recall evidence

Device product

3/16 in. Curved Trocar with Wound 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.

Z-1570-2015

March 26, 2015

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 70841
Status
Terminated
Classification
Class II
Quantity
628 boxes (6,280 each)
Official record key
device-enforcement:Z-1570-2015

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: 0225-015-000 and lot numbers: 10083012 10349012 11224012 12151012 13092012 13196012 14034012 14246012 10125012 11014012 11257012 12286012 13119012 13248012 14127012 14263012 10162012 11059012 12039012 12341012 13135012 13274012 14165012 10273012 11108012 12075012 13010012 13172012 13326012 14177012 10309012 11160012 12080012 13065012 13191012 14021012 14231012

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