PlainRecalls
FDA Devices Moderate Class II Terminated

Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.

Reported: May 13, 2015 Initiated: March 26, 2015 #Z-1573-2015

Product Description

Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.

Reason for Recall

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Details

Units Affected
2,575 boxes (25,750 each)
Distribution
Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Location
Portage, MI

Frequently Asked Questions

What product was recalled?
Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 2,575 boxes (25,750 each).
Why was this product recalled?
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Which agency issued this recall?
This recall was issued by the FDA Devices on May 13, 2015. Severity: Moderate. Recall number: Z-1573-2015.