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Neuron Delivery Catheter 053 (2013-12-13)
- Starting date:
- December 13, 2013
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38287
Recalled Products
Neuron Delivery Catheter 053
Reason
Feedback from a hospital indicated that two Neuron Delivery Catheter 053's received on an order were labeled PND6F10512 (lot F37120) on the outer product box but the device labeling on the pouch inside the box read PND6F1056M (lot F37125). It was determined that devices inside pouches are PND6F10512 devices consistent with the outer product box label.
Affected products
Neuron Delivery Catheter 053
Lot or serial number
F37120
Model or catalog number
PND6F10512
Companies
- Manufacturer
-
Penumbra Inc.
1351 Harbor Bay Parkway
Alameda
94502
California
UNITED STATES