It comes to our attention that the Notified Body National Standards Authority of Ireland (NSAI) has suspended the Quality Management Systems Certificates (ISO 13485) for Hospira's manufacturing facilities in Lake Forest and Costa Rica with effect from 28 February 2013.
The Health Canada and The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom had posted safety alerts on their website to inform the public of the issue and the current actions taken by the manufacturer. Details could be found at the following websites:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/25869a-eng.php
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26209a-eng.php
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON244550
According to Hospira, all new infusion pumps are being held globally under quarantine status, and no new pumps are to be placed on the market until the certificate suspension is lifted. However, the infusion pumps in fields are still to be serviced, maintained and repaired. Healthcare professionals are advised to weight the risk/ benefit to patients associated with the use of the device when administering critical therapies. Customers are advised to consider the use of an alternative pump, particularly in patients in which a delay/ interruption of therapy could result in serious injury and death.
In Hong Kong, the following Hospira infusion pumps are listed under the Medical Device Administrative Control System (MDACS):
In view of the failure in complying with the MDACS requirements, the above products were temporarily delisted with immediate effect. The status of this temporary delisting will be reviewed 3 months later from today.
Posted on 22 March 2013