—#106687

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K101677
Affected lot / code info: list 14203-28, lot 96-146-5H

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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: hospira2573@stericycle.com. Please contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Distributed in the states of North Carolina and Washington.

Timeline

Recall initiated: 2012-01-12
Posted by FDA: 2012-01-19
Terminated: 2016-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106687. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.