Z-0817-2012

Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer...

Name: Z-0817-2012 Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer...
Creator: Hospira Inc.
Published: 2012-01-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-01-12 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per... on 2012-01-12. The reason FDA records is "Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0817-2012
Status: Terminated
Initiated: 2012-01-12
Posted: 2012-01-19
Terminated: 2016-08-29
Recalling firm: Abbott Medical
Product: Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 14203-28. Intended use: for the administration of blood products.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated January 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and immediately quarantine any affected product. Additionally, a Reply Form was attached for customers to complete and return via fax to 1-866-912-8410 or e-mail to: [email protected]. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Quantity in commerce: 960 units
Distribution: Distributed in the states of North Carolina and Washington.
Product codes and lots: list 14203-28, lot 96-146-5H

Product code FPA

K101677Class IIHospira Infusion Blood SetsHospira, Inc. / cleared 2010-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)