|
 

Medical Device Alert: Portex® endotracheal tube holder (2.5mm and 3.0mm) manufactured by Smiths Medical (MDA/2014/036)

This medical device alert is issued due to the risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked.

 

MHRA

CAS deadlines
Action underway: 24 September 2014, action complete: 8 October 2014

Note: These deadlines are for devices to be quarantined.

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits.

Manufactured by Smiths Medical.

Specific product codes and lot numbers.

If relevant to you, the national supply codes are as follows:

Scotland SKU:

Smiths code

NDC code

H4001PS

054220

H4001S

007424

H4002PS

014408

H4002S

039364

H4051

-

H4052

-

England NPC: use manufacturer's codes in the FSN
Northern Ireland: use manufacturer's codes in the FSN
Wales NSV: use manufacturer's codes in the FSN

Risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. There may also be difficulty locking the holder.

This is due to a manufacturing problem, which means the holder might compress the endotracheal tube.

Smiths Medical has issued a Field Safety Notice (FSN)PDF file (opens in new window) (293Kb) recalling affected devices but hasn't had sufficient confirmation that customers have received it and acted on it.

 

 

qr code

 
 
About The Operating Theatre Journal

The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

More »
Follow & Share

Follow The Operating Theatre Journal on Facebook Follow The Operating Theatre Journal on Twitter Follow The Operating Theatre Journal on LinkedIn Follow The Operating Theatre Journal RSS Feed

Help & Support

Problems with, or comments about, this website may be emailed to:
webmaster@lawrand.com

Get in touch

Telephone: +44 (0)2921 680068
Skype: Lawrand Ltd
Email: admin@lawrand.com