6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054. Intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
FDA Recall Z-1634-2008 · Posted 2008-08-13
Recall StatusTerminated
Product CodeDQY
Date Initiated2008-03-17
Date Terminated2011-07-07
Product Quantity7 units
Reason for Recall
Mislabeling: The part number on the product label packaging may not match the product.
Firm Action
Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution.
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.