—#49765

Product

LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K830014
Affected lot / code info: List 12163-01, lot 39-126-5H

Why it was recalled

The tubing can separate from the set at the filter inlet post.

Root cause (FDA determination)

Other

Action the firm took

Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-12-20
Posted by FDA: 2007-02-27
Terminated: 2008-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49765. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.