Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2015 - (Recall #: Z-1573-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 26, 2015

Date Posted: May 13, 2015

Recall Number: Z-1573-2015

Event ID: 70841

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,575 boxes (25,750 each)

Code Information:

Part Number:0225-028-852 and lot numbers: 10097012 10281012 11087012 11178012 12066012 12335012 13234012 14178012 10105012 10298012 11095012 11189012 12101012 12348012 13248012 14197012 10130012 10312012 11105012 11206012 12108012 12353012 13263012 14254012 10162012 10322012 11115012 11229012 12138012 13046012 13302012 14260012 10172012 10337012 11130012 11269012 12156012 13086012 13319012 10195012 10340012 11139012 11313012 12159012 13095012 14029012 10205012 11003012 11146012 11337012 12199012 13108012 14052012 10238012 11013012 11147012 12016012 12248012 13143012 14058012 10251012 11048012 11151012 12040012 12261012 13171012 14155012 10272012 11055012 11160012 12041012 12289012 13221012 14164012

Distribution Pattern:

Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated