Alerta De Seguridad para Intravascular Administration Sets

Safety alert

2013-08-15

2013-08-15

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130815a.html

Medical device safety alert: hospira intravascular administration sets the united states food and drug administration (fda) has issued a medical device safety alert concerning intravascular administration sets, manufactured by hospira inc. please see below the list number of the affected products: 14200-04-28: secondary blood set 14203-04-28: blood set 14206-04-28: y-type blood set 14207-04-28: blood set 14210-04-28: plum blood set 14211-04-28: plum blood set 14212-04-28: plum y-type blood set 14217-04-28: y-type blood set 14219-04-28: y-type blood set according to the fda, it was discovered that there was a potential for the piercing pin on certain iso-compliant hospira blood sets to puncture the outer wall of the non-iso-compliant blood bags during insertion of the pin into the blood bag. this can lead to the leakage of blood and health care provider exposure to blood products. a delay of therapy may also occur and in some cases result in serious adverse health consequences or death. at this time, there is no need for customers to discontinue use of or return hospira blood sets. the manufacturer recommends users exercise extreme caution when piercing blood bags with a hospira blood set mentioned above. the affected users are advised to make sure that all instructions for use included with the blood bag and protocol for spiking blood bags are completely followed, to minimize the possibility of puncturing the outer wall of the blood bag. the manufacturer has begun distribution of sets with a blunter, shorter piercing pin than the affected sets. these sets became available in march, 2013. for details, please visit the following fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=65689&w=08142013&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm364973.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm364988.Htm http://www.Fda.Gov/safety/recalls/ucm364935.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 august 2013.