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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 Drains see related information
Date Initiated by Firm March 26, 2015
Date Posted May 01, 2015
Recall Status1 Terminated 3 on December 31, 2015
Recall Number Z-1565-2015
Recall Event ID 70841
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
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 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: 0215-018-200 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
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Angela 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
Action An 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 Commerce 3,177 boxes (31,770 each)
Distribution Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Total Product Life Cycle TPLC 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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