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U.S. Department of Health and Human Services

Class 2 Device Recall Arthroscopy Outflow/Suction Tubing

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  Class 2 Device Recall Arthroscopy Outflow/Suction Tubing see related information
Date Initiated by Firm September 10, 2010
Date Posted March 25, 2011
Recall Status1 Terminated 3 on January 31, 2012
Recall Number Z-1821-2011
Recall Event ID 58017
Product Classification Catheter, infusion - Product Code JCY
Product ***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900***

For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Code Information Lot:  22747-000, 22748-000, 22749-000.
Recalling Firm/
Manufacturer		 Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo FL 33773-4908
For Additional Information Contact Roger Murphy
727-392-6464
Manufacturer Reason
for Recall		 On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
FDA Determined
Cause 2		 Other
Action Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit. Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office. If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701. If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.
Quantity in Commerce 4,598
Distribution Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain.
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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