3/16 in. Round Drain with Trocar Curved Trocar with recall: Sterility Concern
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…
Why was 3/16 in. Round Drain with Trocar Curved Trocar with 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: 0215-031-000 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
- 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…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 648 boxes (6,480 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)