Stryker Instruments Div. of Stryker Corporation: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Agency Publication Date: May 1, 2015

Affected Products

Product: 3/16 in. Trocar with Single 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.

Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012

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Product: 3/16 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.

Part Number: 0215-015-200 and lot numbers: 10074012 10280012 11110012 11271012 12066012 12349012 13225012 14022012 10105012 10294012 11138012 11298012 12080012 13016012 13260012 14070012 10118012 10315012 11151012 11346012 12091012 13077012 13268012 14163012 10155012 10319012 11185012 11356012 12181012 13115012 13303012 14169012 10215012 10344012 11189012 12025012 12275012 13120012 13323012 14195012 10242012 11025012 11264012 12053012 12290012 13148012 13346012 14246012 10252012 11033012

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Product: 1/8 in. Trocar with Single 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.

Part Number: 0215-018-000 and lot numbers: 10076012 10284012 11108012 11280012 12110012 12334012 13158012 14020012 10095012 10292012 11117012 11298012 12131012 12338012 13182012 14050012 10103012 10295012 11125012 11305012 12143012 12339012 13191012 14056012 10112012 10307012 11136012 11308012 12153012 12348012 13220012 14059012 10125012 10319012 11143012 11339012 12158012 12352012 13227012 14076012 10133012 10335012 11145012 11343012 12160012 13011012 13238012 14083012 10137012 10342012 11146012 11356012 12164012 13035012 13239012 14147012 10160012 10356012 11157012 12012012 12181012 13050012 13261012 14165012 10175012 11010012 11161012 12019012 12188012 13059012 13262012 14169012 10188012 11014012 11187012 12030012 12242012 13078012 13274012 14174012 10205012 11026012 11204012 12051012 12255012 13091012 13281012 14189012 10222012 11032012 11221012 12053012 12262012 13099012 13298012 14190012 10228012 11043012 11230012 12055012 12277012 13106012 13323012 14231012 10237012 11053012 11249012 12061012 12292012 13113012 13324012 14233012 10252012 11069012 11251012 12065012 12303012 13138012 13340022 14245012 10266012 11088012 11265012 12081012 12313012 13144012 13351012 14280012 10273012 11103012 11269012 12091012 12317012 13155012 14017012 14344012

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Product: 1/8 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.

Part Number: 0215-018-200 and lot numbers: 10082012 10266012 11089012 11222012 12047012 12240012 13121012 14034012 10099012 10289012 11109012 11231012 12059012 12256012 13145012 14072012 10105012 10309012 11122012 11241012 12072012 12283012 13156012 14083012 10118012 10319012 11129012 11252012 12080012 12319012 13194012 14164012 10134012 10323012 11136012 11271012 12125012 12332012 13235012 14170012 10168012 10342012 11143012 11305012 12144012 12349012 13260012 14234012 10180012 11012012 11151012 11337012 12152012 13015012 13275012 10217012 11035012 11168012 11355012 12157012 13039012 13317012 10229012 11052012 11188012 12004012 12178012 13057012 13343012 10256012 11070012 11199012 12027012 12198012 13086012 14016012

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Product: 1/4 in. Trocar with Single 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.

Part Number: 0215-019-000 and lot numbers: 10095012 10312012 11060012 11186012 11346012 12115012 12349012 13262012 10109012 10321012 11067012 11192012 11356012 12157012 13017012 13277012 10127012 10347012 11088012 11220012 12003012 12193012 13023012 13347012 10189012 10355012 11097012 11230012 12009012 12206012 13044012 14020012 10195012 11011012 11117012 11269012 12026012 12235012 13063012 14030012 10274012 11039012 11136012 11286012 12031012 12290012 13145012 14039012 10285012 11059012 11178012 11335012 12060012 12310012 13254012 14066012

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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.

Part Number: 0215-019-200 and lot numbers: 14122012

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Product: 3/16 in. Round Drain with Trocar 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.

Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 14044012 10104012 10263012 11012012 11185012 12053012 12237012 13126012 14147012 10147012 10279012 11055012 11216012 12082012 12318012 13163012 14153012 10153012 10309012 11110012 11252012 12116012 12331012 13211012

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Product: 1/4 in. Round Drain with Trocar 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.

Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012

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Product: 3/16 in. Curved 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.

Part Number: 0225-015-000 and lot numbers: 10083012 10349012 11224012 12151012 13092012 13196012 14034012 14246012 10125012 11014012 11257012 12286012 13119012 13248012 14127012 14263012 10162012 11059012 12039012 12341012 13135012 13274012 14165012 10273012 11108012 12075012 13010012 13172012 13326012 14177012 10309012 11160012 12080012 13065012 13191012 14021012 14231012

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Product: 1/8 in. Curved 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.

Part Number:0225-018-000 and lot numbers: 10081012 10272012 11060012 11223012 12074012 13002012 13254012 14167012 10123012 10295012 11104012 11259012 12115012 13022012 13290012 14174012 10138012 10321012 11124012 11284012 12201012 13053012 13318012 14252012 10162012 10334012 11137012 11320012 12250012 13060012 13345012 10182012 10341012 11143012 11361012 12293012 13095012 14031012 10228012 11007012 11188012 12018012 12317012 13138012 14085012 10245012 11043012 11207012 12046012 12340012 13221012 14149012

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Product: 1/4 in. Curved 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.

Part Number:0225-019-000 and lot numbers: 10111012 11018012 11273012 12296012 13066012 13175012 14029012 14143012 10131012 11115012 12237012

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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.

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

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70841

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States

Units Affected: 12 products (2,711 boxes (27,110 each); 1,375 boxes (13,750 each); 6,424 boxes (64,240 each); 3,177 boxes (31,770 each); 1,984 boxes (19,840 each); 4 boxes (40 each); 648 boxes (6,480 each); 300 boxes (3,000 each); 628 boxes (6,280 each); 1,457 boxes (14,570 each); 120 boxes (1200 each); 2,575 boxes (25,750 each))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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Part Number: 0215-019-200 and lot numbers: 14122012

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Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012

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Part Number:0225-019-000 and lot numbers: 10111012 11018012 11273012 12296012 13066012 13175012 14029012 14143012 10131012 11115012 12237012

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Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70841

Status: Resolved

Manufacturer: Stryker Instruments Div. of Stryker Corporation

Manufactured In: United States