—#97966

Product

Rusch Irrigation Tray w/Bulb Catalogue Number 68895 For irrigation according to institutional guidelines.

FDA product code: KMJ — Lubricant, Patient
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-02-24
Posted by FDA: 2011-04-05
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97966. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.