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Z-1571-2015 Class II Terminated

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

FDA device recall Z-1571-2015 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: 1,457 boxes (14,570 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: 1,457 boxes (14,570 each)

Product description

1/8 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:0225-018-000 and lot numbers: 10081012 10272012 11060012 11223012 12074012 13002012 13254012 14167012 10123012 10295012 11104012 11259012 12115012 13022012 13290012 14174012 10138012 10321012 11124012 11284012 12201012 13053012 13318012 14252012 10162012 10334012 11137012 11320012 12250012 13060012 13345012 10182012 10341012 11143012 11361012 12293012 13095012 14031012 10228012 11007012 11188012 12018012 12317012 13138012 14085012 10245012 11043012 11207012 12046012 12340012 13221012 14149012

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1571-2015
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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