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Intravascular Administration Sets Recalled; Potential for Blood Bag Puncture


Hospira Inc. recalled its intravascular administration sets manufactured from July 2011 through February 2013 and distributed from July 2011 through February 2013. The recall affects the following 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, and
  • 14219-04-28 Y-Type Blood Set.

The Hospira blood sets are used for administration of blood and blood products.

                          

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.

 

Hospira recommends users exercise extreme caution when piercing blood bags with a Hospira blood set mentioned above. Make sure that all instructions for use included with the blood bag and your facility's protocol for spiking blood bags are completely followed, to minimize the possibility of puncturing the outer wall of the blood bag. Hospira has begun distribution of sets with a blunter, shorter piercing pin than the sets in the Impacted List Numbers.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

 

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