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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump

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  Class 2 Device Recall Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump see related information
Date Initiated by Firm February 01, 2010
Date Posted September 03, 2010
Recall Status1 Terminated 3 on March 28, 2011
Recall Number Z-2358-2010
Recall Event ID 54625
510(K)Number K030661  
Product Classification Pump, infusion, pca - Product Code MEA
Product Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile, Product of Ireland Manufactured for Stryker Instruments, Kalamazoo, MI.
Code Information 2009042103.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Angela Regainis
269-323-7700
Manufacturer Reason
for Recall		 Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
FDA Determined
Cause 2		 Process control
Action Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354
Quantity in Commerce 18,826 all products
Distribution Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.
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 = MEA and Original Applicant = STRYKER INSTRUMENTS
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