Reported May 13, 2015 · Terminated
1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 1/4 in. Trocar with Single Drain Curved Trocar with Wound
- Drain/Double Trocar with Wound DrainThe 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
- Lot codes and dates
- Part Number0215-019-000
- and lot numbers
1009501210312012110600121118601211346012121150121234901213262012101090121032101211067012111920121135601212157012130170121327701210127012103470121108801211220012120030121219301213023012133470121018901210355012110970121123001212009012122060121304401214020012101950121101101211117012112690121202601212235012130630121403001210274012110390121113601211286012120310121229001213145012140390121028501211059012111780121133501212060012123100121325401214066012
- Amount recalled
- 1,984 boxes (19,840 each)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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