Home / Recalls / Stryker Instruments Div. Of Stryker Corporation / Z-1573-2015

Z-1573-2015 Class II Terminated

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

FDA device recall Z-1573-2015 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: 2,575 boxes (25,750 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: 2,575 boxes (25,750 each)

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

Distribution pattern

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

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1573-2015
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.

Other recalls by Stryker Instruments Div. Of Stryker Corporation

Z-1452-2022 Class II — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number… (Jun 15, 2022)
Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile… (Oct 16, 2020)
Z-1807-2020 Class II — Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product… (Mar 26, 2020)
Z-1402-2022 Class II — Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG… (Jan 22, 2020)
Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is… (Jan 13, 2020)
Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The… (Jan 13, 2020)
Z-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie… (Jan 13, 2020)
Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder)… (Nov 6, 2019)
Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder)… (Nov 6, 2019)
Z-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage… (Jul 31, 2019)