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Class I Medical Device Recall: Hospira Intravascular Administration Sets

Wed, 08/14/2013 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: April 1, 2013

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

These affected products were manufactured from July, 2011 through February, 2013 and distributed from July, 2011 through February, 2013.

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

Recalling Firm:
Hospira Inc.
275 N. Field Dr.
Lake Forest, IL 60045
FEI No. 3005579246

Manufacturer:
Hospira Costa Rica Ltda.
La Aurora De Heredia,
1 Km Noreste DPlaza
Real Cariari,
Global Park De Entrada 300,
Mt Oeste Heredia, CR
FEI No. 3002999813

Reason for Recall: 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.

Public Contact: For questions about this action, contact Hospira Medical Communications at 1-800-615-0187 (24 hours a day/ 7 days a week) or email: medcom@hospira.com. To report a complaint, contact Hospira Global Complaints at 1-800-441-4100 (8:00 am – 5:00 pm CT, Monday through Friday) or email: ProductComplaints@hospira.com

FDA District: Chicago District Office

FDA Comments:

Health Care Professionals: At this time, there is no need for customers to discontinue use of or return Hospira blood sets. 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. These sets became available in March, 2013. Customers should contact Hospira or their local representative for information about these sets.

On April 1, 2013, Hospira contracted with Stericycle, Inc. to mail the Firm’s Safety Information letter disclaimer icon to affected customers via UPS. On April 2, 2013, the letter was also sent via email to Emergency Care Research Institute, Noblis (RASMAS), Institute for Safe Medication Practices, National Recall Alert Center, the Army, and the Veterans Administration. On Aug 13, 2013, Hospira posted an updated Safety Information letter disclaimer icon on its website. For a copy of the firm’s letter, call Stericycle at 1-866-608-3936 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.

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