U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Catheter, percutaneous - Product Code DQY
원인
Leakage-- due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.
조치
Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra.
For further information, contact Penumbra, Inc. at 1-510-748-3223.
Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.
제품 설명
Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. || Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.