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Terminated

Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54, Distributed by: Hospira, Inc. Morgan Hill, CA

FDA Recall Z-2391-2010 · Posted 2010-09-09

Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-02-22
Date Terminated2011-04-01

Reason for Recall

The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.

Firm Action

Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041550HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREAbbott Laboratories · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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