Arterial Catheterization Set
FDA Recall Z-2494-2010 · Posted 2010-09-25
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2010-07-29
Date Terminated2012-07-05
Product Quantity9
Reason for Recall
Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
Firm Action
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
Root Cause
Mixed-up of materials/components
Distribution Pattern
The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
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.