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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-1571-2015
Recall Event ID 70841
510(K)Number K970714  
Product Classification Apparatus, autotransfusion - Product Code CAC
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 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: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
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 1,457 boxes (14,570 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.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = STRYKER INSTRUMENTS
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