Intravenous pump set: Lifeshield Primary Plumset.
Specific list numbers and lot numbers are affected.
List number
Lot numbers
Set description
14000-92-28
27112-5H
30079-5H
Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Prepierced Y-site, 272 cm
14001-92-38*
28187-5H
Lifeshield, latex-free, non-DEHP, Primary Plumset, 15 micron filter in sight chamber, Clave port, Clave Y-site, 272 cm
*the equivalent NHS Supply Chain code for this list number is FSB1314 (England only).
NHS Supply Chain has sent its own customer notice about this recall (reference NHS SC 32).
Intravenous administration sets: Primary PlumSet Clave secondary port.
Specific list numbers are affected.
All lots manufactured after July 2007 of the following list numbers have been supplied to the UK and are affected:
140010728
140018328
140019228
140149228
142129228
196735324
Note that any other list numbers detailed in the FSN have
not
been supplied to the UK
GemStar docking station for use with specific GemStar infusion pumps.
The specific products potentially affected by the two problems are shown below:
Affected product (docking station list numbers)
Issue
Potential to occur in conjunction with products
13075-XX-07
13075-XX-09
Pump fails to power up
Gemstar phase 3 pump
(13000-XX, 13100-XX, 13150-XX)
Error code 11/003 on pump and infusion stops
Gemstar phase 4 pump
(13086-XX, 13087-XX, 13088-XX)
External battery pack
(13073-XX)
If you are unsure whether the Gemstar infusion pump is a phase 3 or a phase 4 contact Hospira for clarification.
There is no corrective action in place to resolve this issue. Hospira is offering the Sapphire pump, manufactured by Q Care, on a part exchange basis to replace Gemstar pumps as detailed in Medical Device Alert
MDA/2013/078
.