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

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 CodeProduct 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
ReorderReorderReorderReorderReorderReorderReorderReorderReorderReorder
CodeCodeCodeCodeCodeCodeCodeCodeCodeCode
H4001PSH4001SH4001SH4002PSH4002SH4002SH4051H4051H4052H4052
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.

Contacts:

Smiths Medical
Judith Rossi, +1 781-792-2539

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