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

[August 21, 2014]

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

ST. PAUL, Minn. --(Business Wire)--

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.

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.


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