Recall Z-1573-2015— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1573-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-26

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2015-03-26, terminated 2015-12-31. It names one FDA 510(k) clearance: K970714. Product: 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: 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

510(k) clearances named in this recall

1 on FDA's record

K970714 — STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)Stryker Instruments·cleared 1997-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.