—#93828

Product

Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550
Affected lot / code info: List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54.

Why it was recalled

If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.

Root cause (FDA determination)

Device Design

Action the firm took

Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.

Timeline

Recall initiated: 2010-03-26
Posted by FDA: 2010-09-08
Terminated: 2012-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.