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Terminated

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

FDA Recall Z-2381-2010 · Posted 2010-09-08

Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-03-26
Date Terminated2012-03-30
Product Quantity28485 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, 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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