Hospira Blood Set Recall Issued Due to Risk of Leakage, Death

A number of blood sets have been recalled by Hospira following a report of involving a patient death that may have been caused by a punctured blood bag.  

The Hospira Intravascular Administration Set recall was announced earlier this year, but this week the FDA classified it as a class I medical device recall, meaning the agency believes the blood products put patients at risk of serious injury or death. The recalled Hospira blood sets are used for administering blood and blood products to patients with blood cell reproduction illnesses.

The affected blood sets come with an International Organization for Standardization (ISO)-compliant pin with a sharp point that may potentially puncture the outer wall of the bags when inserting the pin in the bag which could cause a delay in treatment to the patient. Depending on the severity of the patient’s condition, a delay in treatment could lead to significant injury or death.

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The recall affects a number of Hospira intravascular administration sets, often referred to as blood sets. The following list numbers are included in the recall; 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. These sets were distributed July 2011 through February 2013.

The recalled Hospira blood sets were manufactured by Hospira Costa Rica Ltda., from July 2011, through February 2013 and distributed nationwide from July 2011, through February 2013.

The FDA announced that users with affected blood sets do not have to stop using the product but should be extremely cautious when inserting the pin into the blood bag to not puncture the outer wall.

To prevent puncturing the bags Hospira began distributing sets of shorter and duller ended pins in March.

Class I recalls are the highest level of recall due to the reasonable probability that the use of the product or close contact with the product will cause serious adverse health consequences or death.

Users with affected products should be extremely cautious when handling the IOS pin insertion process and contact Hospira at 1-800-441-4100 or email them at productcomplaints@hospira.com for further inquiry or concerns.


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