Smiths Medical Issues Urgent Medical Device Recall of Certain Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm

  Smiths Medical Issues Urgent Medical Device Recall of Certain Portex®   Endotracheal Tube Holders, 2.5mm and 3.0mm  Business Wire  ST. PAUL, Minn. -- August 21, 2014  Smiths Medical, a leading global medical device manufacturer, announced today that it is initiating a nationwide recall of certain lots of Portex® Endotracheal Tube Holders sold as stand-alone products and packaged in intubation kits. The FDA has been made aware of this action.  Smiths Medical is voluntarily recalling these products because a small number of customers have reported difficulty when passing a suction catheter through the Endotracheal Tube when the holder is locked, or have experienced difficulty when locking the holder. These conditions could present a delay in therapy while replacement product is obtained, or could result in an accidental tube extubation if the Endotracheal Tube Holder fastener is loosened in an effort to suction the patient. A copy of the customer notification letter is posted on the Smiths Medical website at www.smiths-medical.com.  In some reports of issues with passing the suction catheter through the Endotracheal Tube, customers were attempting to use 6 Fr suction catheters with 2.5mm Endotracheal Tubes. Smiths Medical recommends the use of 5 Fr suction catheters with 2.5mm Endotracheal Tubes. For a guidance chart on Tracheal Tube/ Suction Catheter sizes, please access the chart at the Smiths Medical website at http://www.smiths-medical.com/plugins/news/2014/aug/urgent-medical-device-recall.html.  Consumers who have the Affected Tube Holders should:  1.Inspect your inventory and segregate any unused affected products (refer     to the list below); and 2.Complete and return the Confirmation Form (located at     http://www.smiths-medical.com), either by fax at +1-800-621-2590 or by     e-mail to: EndoTrachealTubeHolders@smiths-medical.com within 7 days of     receipt of this notice.  Upon receipt of the completed form, a customer service representative will contact you to arrange for exchange of your unused affected inventory for credit or replacement.  Details of Affected Devices: Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm                         Product Reorder Code   Product Name and Description H4001PS                Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm                          Conn H4001S                 Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn,                          Holder H4002PS                Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm                          Conn H4002S                 Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn,                          Holder H4051                  Endo Tube Holder, Pedi 2.5mm H4052                  Endo Tube Holder, Pedi 3.0mm                                                                                                           Reorder   Reorder   Reorder   Reorder   Reorder   Reorder   Reorder   Reorder   Reorder   Reorder Code        Code        Code        Code        Code        Code        Code        Code        Code        Code H4001PS   H4001S    H4001S    H4002PS   H4002S    H4002S    H4051     H4051     H4052     H4052 Lot No.   Lot No.   Lot No.   Lot No.   Lot No.   Lot No.   Lot No.   Lot No.   Lot No.   Lot No. 2470635   2470637   2339700   2474641   2481849   2376489   2597332   2228363   2602399   2175057 2453453   2470636   2335460   2470638   2474643   2365439   2585074   2219213   2588625   2154535 2443370   2457747   2326892   2453454   2470640   2361588   2580798   2211929   2580799   2152054 2438608   2448649   2322812   2448650   2470639   2343298   2576365   2208194   2576366   2146301 2412131   2443371   2309462   2438611   2465819   2329576   2564404   2191930   2523679   2142179 2394050   2438610   2298736   2433436   2462292   2326894   2564403   2179229   2513119   2135984 2380339   2438609   2298735   2428205   2462291   2322814   2563088   2175056   2492246   2128636 2380338   2428204   2286584   2412133   2457748   2317088   2549367   2154534   2481855   2120121 2376475   2428203   2278061   2400804   2453455   2309465   2519413   2142178   2474647   2116100 2361590   2423483   2263550   2347041   2448671   2309464   2500170   2135983   2465829   2109019 2352067   2412132   2260549   2343292   2443372   2298739   2488207   2128635   2457754   2090224 2322810   2405733   2250041   2326893   2438612   2298738   2474646   2124241   2443379   2077180 2271334   2405732   2233738   2298737   2428206   2286586   2465828   2120119   2438616   2068123 2260548   2394049   2228354   2271338   2420088   2278062   2453473   2116099   2433451   2063991 2223901   2394048   2219206   2260550   2412135   2271339   2443378   2090223   2428215   2063990 2208177   2394047   2211922   2211923   2394046   2188449   2438615   2077179   2412146   11889 2202236   2389237   2208179   2188448   2394045   2179222   2433450   2063989   2394061   11870 2191909   2389236   2191911   2175049   2394044   2164289   2412145   2063988   2380352   11859 2161059   2385647   2188447   2135974   2385648   2146292   2380351   12040     2376566   11697 2077168   2380340   2179221   2099500   2380341   2142175   2376498   12033     2365454   11695 2042400   2376638   2175047   2068120   2376618   2137959   2365494   11877     2361579   11694 12050     2376473   2154527   2042404            2128629   2365493   11876     2357822   11657          2371941   2152029   11872              2119945   2361580   11874     2347642   11654          2365534   2142174   11861              2109011   2357823   11873     2343312   11406          2361589   2128628                     2099501   2353347   11679     2343311             2357817   2119944                     2090215   2343313   11655     2329584            2357816   2109010                     2068121   2329583   11407     2322827             2353342   2099495                     2063971   2326899   11405     2309473             2347040   2090213                     2063970   2322825            2298755             2343290   2068117                     2042408   2298752            2298754                      2063968                     12046     2286594            2286596                      2063967                     11871     2278069            2271359                      2042403                     11862     2271358            2250054                      12049                       11858     2263553            2244752                      12047                       11696     2260562            2244751                      12044                       11693     2260561            2228364                      11669                       11656     2250053            2211930                      11403                       11653     2250052            2208196                                                          2250050            2191931                                                          2250049            2188460                                                          2244749            2179231                                                                                                                  Smiths Medical is notifying affected customers via Fedex. Recipients of the Urgent Medical Device Recall Notice who have distributed the affected products to other persons or facilities should promptly forward a copy of the Urgent Medical Device Recall Notice accordingly.  For questions regarding this recall, customers should contact:  Smiths Medical Customer Service (Monday – Friday 8am – 8pm CST) 800-258-5361, Option 1 EndoTrachealTubeHolders@smiths-medical.com  Customers should report any issues with the Portex® Endotracheal Tube Holders to Smiths Medical’s Global Complaints Department at globalcomplaints@smiths-medical.com or 1-866-216-8806.  Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.    *Online at www.fda.gov/MedWatch/report.htm   *Regular Mail; use postage-paid, pre-addressed Form FDA 3500 available at:     www.fda.gov/MedWatch/getforms.htm   *Fax 1-800-FDA-0178.  About Smiths Medical Smiths Medical  www.smiths-medical.com is a leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group www.smiths.com, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components.Smiths Group employs around 22,000 people in more than 50 countries.  Contact:  Smiths Medical Judith Rossi, +1 781-792-2539  
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