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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch Irrigation Tray w/Bulb

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  Class 2 Device Recall Rusch Irrigation Tray w/Bulb see related information
Date Initiated by Firm February 24, 2011
Date Posted April 05, 2011
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-1897-2011
Recall Event ID 58011
Product Classification Lubricant, patient - Product Code KMJ
Product Rusch Irrigation Tray w/Bulb Catalogue Number 68895

For irrigation according to institutional guidelines.
Code Information Catalogue Number 68895: Lot Numbers: 002516, 002520, 003512, 004513, 005510, 005528, 006510, 007513, 009512, 010507, 011506, 011511, 012514, 901524, 901545, 902506, 902519, 903508, 904511, 905502, 907516, 907528, 908518, 911512 and 912503.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Robert Philips
610-478-3138
Manufacturer Reason
for Recall		 The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination.
FDA Determined
Cause 2		 Other
Action the firm,Teleflex Medical, sent two "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters one dated February 24, 2011 and the other dated March 30, 2011 to all consignees and customers. The letters described the product, problem and actions to be taken. The consignees were instructed to communicate the recall to any of their customers who have received product included within the scope of the field corrective action via the customer letter. The customers were informed in the letter of concerns about potential bacterial contamination of the alcohol prep pads in the affected trays. If contaminated alcohol prep pads are used, there is a potential for infection to occur. The customers were instructed "that upon opening the affected trays for use, they should discard the prep pads as medical waste". The customers were also instructed to immediately discontinue use and quarantine any products with the product numbers and lot numbers listed; return the product, and complete and return the Recall Acknowledgement Form, even if they no affected product, via fax to 1-866-804-988, Attn: Customer Service (a customer service representative contact the customer with a Return Goods Authorization number and instructions for the return of the product to Teleflex Medical). If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce see line 1.
Distribution Worldwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, MS, MI, MO, MS, NC, NJ, NH, NY, OH, PA, TX, UT, VA, Puerto Rica and the country of: Canada.
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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