Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
FDA Recall Z-2313-2009 · Posted 2009-09-24
Advertisement
Recalling FirmPenumbra Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-07-01
Date Terminated2010-11-30
Product Quantity37 units
Reason for Recall
Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
Firm Action
Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
Root Cause
Mixed-up of materials/components
Distribution Pattern
CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
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.
Advertisement