FDAClass IIMay 13, 2015

1/4 in. Round Drain with Trocar Curved Trocar with recall: Sterility Concern

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…

Why was 1/4 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: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012

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…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
300 boxes (3,000 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