3/16 in. Double Trocar with Wound Drain Curved Trocar recall: Sterility Concern
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…
Why was 3/16 in. Double Trocar with Wound Drain Curved Trocar recalled?
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 1,375 boxes (13,750 each)
- Distribution
- Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
- Recall date
- May 13, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)