Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Woundcare Tubing Replacement Sets

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stryker Woundcare Tubing Replacement Setssee related information
Date Initiated by FirmMay 08, 2015
Date PostedJuly 13, 2015
Recall Status1 Terminated 3 on October 19, 2015
Recall NumberZ-2062-2015
Recall Event ID 71271
Product Classification Lavage, jet - Product Code FQH
Product0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
Code Information 0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactJulie Forsyth
269-323-7700
Manufacturer Reason
for Recall		Potential sterility breach in the packaging.
FDA Determined
Cause 2		Package design/selection
ActionStryker sent Customer Notification Letters on 05/20/2015 through Certified mail via USPS. Customers are asked to do the following: Immediately review this Recall Notification. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Form to Stryker Instruments Regulatory Department. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled WoundCare Replacement kits to Stryker.
Quantity in Commerce5,328 each (444 boxes)
DistributionNationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
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.
-
-