FDAClass IIMay 13, 2015

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

1/8 in. Double 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. 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: 0215-018-200 and lot numbers: 10082012 10266012 11089012 11222012 12047012 12240012 13121012 14034012 10099012 10289012 11109012 11231012 12059012 12256012 13145012 14072012 10105012 10309012 11122012 11241012 12072012 12283012 13156012 14083012 10118012 10319012 11129012 11252012 12080012 12319012 13194012 14164012 10134012 10323012 11136012 11271012 12125012 12332012 13235012 14170012 10168012 10342012 11143012 11305012 12144012 12349012 13260012 14234012 10180012 11012012 11151012 11337012 12152012 13015012 13275012 10217012 11035012 11168012 11355012 12157012 13039012 13317012 10229012 11052012 11188012 12004012 12178012 13057012 13343012 10256012 11070012 11199012 12027012 12198012 13086012 14016012

Product
1/8 in. Double 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
3,177 boxes (31,770 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