Recall Z-1567-2015— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2015-03-26, terminated 2015-12-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 1/4 in. Double 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: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-26
- Terminated
- 2015-12-31
- Firm location
- Portage, MI, United States
Product description
1/4 in. Double 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.