| Class 2 Device Recall Rusch Irrigation Tray w/Piston | |
Date Initiated by Firm | February 24, 2011 |
Date Posted | April 05, 2011 |
Recall Status1 |
Terminated 3 on April 17, 2012 |
Recall Number | Z-1896-2011 |
Recall Event ID |
58011 |
Product Classification |
Lubricant, patient - Product Code KMJ
|
Product | Rusch Irrigation Tray w/Piston Catalogue Number 67890
For irrigation according to institutional guidelines. |
Code Information |
Catalogue Number 67890, Lot numbers: 002508, 002514, 002519, 004514, 005508, 006509, 007510, 009511, 010502, 011502, 011510, 901526, 901543, 902507, 904510, 905501, 906512, 907509, 908502, 908524 and 911513. |
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 | 95,647 eaches (total for both Catalogue Numbers) |
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 |
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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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