NIAIC Whats New
- 19 January 2012
MDA/2012/002 (PDF 21 KB)
Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend. Manufactured by Smiths Medical. Lot numbers from 1631477 to 1923406 inclusive. Incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect. This may cause the tube to dislodge, requiring it to be changed. The manufacturer has initiated a recall of affected tubes. The manufacturer issued a Field Safety Notice (FSN) – dated 15 November 2011 (see appendix 2) – but has not had confirmation from all users that they have received and acted on this information.
- 19 January 2012
EFA/2012/001 (PDF 94 KB)
Integral side-stay mechanism window restrictors fitted with plastic spacers and used in many window applications. Certain types of side-stay window restrictors incorporate a plastic spacer which, if allowed to deteriorate and crack, may result in separation of the retaining rivet and failure of the restrictor. Even with a restrictor fitted to each side of the window, the failure of one restrictor may be enough to allow egress with high risk of injury or death.
- 17 January 2012
MDA/2012/001 (PDF 25 KB)
Rüsch Flexislip/Flexi-Slip™ endotracheal tube stylet with soft distal tip, 6F. Manufactured by Teleflex. Product codes: 502501 size 6Fr and 503700 size Ch 6. Specific lots affected. Teleflex is undertaking a recall following complaints received about two problems: difficulty removing the stylet from the endotracheal tube after intubation, separation of the PVC sheath from the stylet Either problem may result in injury and the need for medical intervention. Teleflex issued a Field Safety Notice (FSN) on 22 November 2011 but has not had sufficient confirmation from users that they have received and acted on this information.
- 22 December 2011
MDA/2011/113 (PDF 48 KB)
Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon. Possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves. The manufacturer issued a Field Safety Notice (FSN) for this device on 27/09/2011, but has not had sufficient confirmation from users that they have received and acted on this information. This alert has been issued in support of the manufacturer's actions.
- 22 December 2011
MDA/2011/112 (PDF 22 KB)
Implantable cardioverter defibrillator ICD leads - Riata Riata ST - St Jude.Risk of inappropriate therapy due to wear and/or abrasion of lead insulation after implantation
- 22 December 2011
EFA/2011/004/Update (PDF 658 KB)
High-Voltage 11KV Switchgear - Schneider Electric - Merlin Gerin - Ringmaster RN2c RE2c and RN6c ring main units The advice given in EFA/2011.004 is still in force but has been supplemented by guidance information from Merlin Gerin/Schneider given in this Update.
