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U.S. Department of Health and Human Services

Class 2 Device Recall CBC II Wound Drains

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 Class 2 Device Recall CBC II Wound Drainssee related information
Date Initiated by FirmMarch 26, 2015
Date PostedMay 01, 2015
Recall Status1 Terminated 3 on December 31, 2015
Recall NumberZ-1562-2015
Recall Event ID 70841
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Code Information Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactAngela Ragainis
269-323-7700
Manufacturer Reason
for Recall		Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
FDA Determined
Cause 2		Package design/selection
ActionAn URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.
Quantity in Commerce2,711 boxes (27,110 each)
DistributionWorldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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