—#125870

Product

Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.

FDA product code: BTS — Tube, Bronchial (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K951091
Affected lot / code info: Product Code - 116200260, Batch 09LE51, 10GE31, 11LE42, 12DE17, 12IE37, 13CT26, 13DT32; Product Code - 116200280 - Batch 09HE34, 09JE41, 10BE07, 11HE33, 11JE41, 13ET12; Product Code - 116200350 - Batch 0918M, 0915M, 09JE43, 09JE42, 0917M, 11AE03, 11DE15, 11GE27, 09HE34, 11JE43, 11JE42, 12AE02, 12BE07, 12DE17, 12EE19, 12GE27, 12HE33, 13AE01, 13CT26, 13DT33, 13ET12; Product Code 116200370 - Batch 0915M, 0917M, 0914M, 09JE41, 09JE43, 11DE15, 11EE20, 11GE27, 11JE42, 11HE32, 11JE43, 11IE39, 12AE01, 12AE03, 12GE31, 12BE06, 12DE18, 12IE39, 12JE44, 13AT44, 13BT44, 13AE01, 12LE49, 13DT33; Product Code 116200390 - Batch 0914M, 0922M, 0917M, 09JE44, 09FE23, 09HE35, 09JE42, 10GE29, 10AE02, 09JE43, 09KE46, 09LE51, 10AE01, 10CE11, 10DE18, 10EE19, 10JE41, 10EE20, 11DE15, 11KE42, 11GE30, 11HH33, 11IE37, 11IE38, 11IE39, 13AT36, 13BT25, 13BT29; Product Code 116200410 - Batch 0922M, 0915M, 0918M, 09IE36, 09JE43, 10AE05, 10BE06, 10DE16, 10GE28, 10JE41, 11DE15, 11GE27, 11HE34, 11JE43, 13BT44, 13DT32; Product Code 116201350 - Batch 0921M, 09JE40, 09FE23, 13GT05; Product Code 116201370 - Batch 0922M, 0915M, 13AE01, 13ET18, 13HT12, 09FE24; Product Code 116201390 - Batch 09JE44, 10CE10; Product Code 116201410 - Batch 10KE47

Why it was recalled

The product may fail to achieve seal of right lung due to the cuff inflating to one side

Root cause (FDA determination)

Device Design

Action the firm took

Teleflex sent a Urgent Medical Device Recall Notification dated February 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other 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 (nationwide) Distribution including Puerto Rico and the states of AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV and WI,and the countries of United Arab Emirates, Austria, Australia, Azerbaijan, Belgium, Belgrade, Bahrain, Canada, Switzerland, Cameroon, China, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guyana, Croatia, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Serbia, Malaysia, Martinique, Nigeria, Netherlands, Norway, Oman, Panama, French Polynesia, Philippines, Poland, Portugal, Qatar, Reunion, Russia, San Salvador, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, San Marino, Thailand, Trinidad, Tunisia, Turkey, Venezuela, Yemen and Zambia

Timeline

Recall initiated: 2014-02-28
Posted by FDA: 2014-03-19
Terminated: 2016-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.