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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Scope Warmer

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 Class 2 Recall
Stryker Scope Warmer
see related information
Date Posted September 29, 2010
Recall Status1 Terminated on December 16, 2010
Recall Number Z-2622-2010
Recall Event ID 56110
Premarket Notification
510(K) Number
K053311 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.
Code Information Model number 502-360-000, all serial numbers
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
Manufacturer Reason
for Recall
Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.
Quantity in Commerce 191855 units
Distribution Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = Stryker Endoscopy
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