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 29, 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 CT)  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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