FDAClass IIMay 13, 2015

1/8 in. Curved Trocar with Wound Drain Curved Trocar recall: Sterility Concern

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…

Why was 1/8 in. Curved 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: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

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…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
1,457 boxes (14,570 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)
Open FDA enforcement record Latest recalls