Catheterization Kits containing Angiographic Syringes with rotator connector.
FDA Recall Z-0621-05 · Posted 2005-03-15
Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2004-11-02
Date Terminated2005-07-25
Product Quantity62080 kits
Reason for Recall
Syringes could possibly allow air to enter the patient's vascular system.
Firm Action
Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Root Cause
Other
Distribution Pattern
Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.