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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