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Z-1570-2015 Class II Terminated

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

FDA device recall Z-1570-2015 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: 628 boxes (6,280 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: 628 boxes (6,280 each)

Product description

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.

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: 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1570-2015
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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