Z-1569-2015 Class II Terminated
FDA device recall Z-1569-2015 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: 300 boxes (3,000 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
- 300 boxes (3,000 each)
Product description
1/4 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.
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: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1569-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026