Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
FDA Recall Z-1801-2008 · Posted 2008-09-11
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2008-04-08
Date Terminated2009-04-06
Product Quantity55 kits
Reason for Recall
Convenience kits may contain non-filtered drip chambers
Firm Action
An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
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.