Recall Z-2313-2009 ยท DQY Catheter, Percutaneous
Penumbra Inc.
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.
| Date | Sep 24, 2009 (initiated Jul 1, 2009) |
| Status | Terminated |
| Reason | Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery' |
| Root cause | Mixed-up of materials/components |
| 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. |
| Quantity | 37 units |
| Distribution | CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070970 | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F Penumbra, Inc., Aug 17, 2007 |