PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
This recall has been terminated (originally issued August 3, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- June 16, 2005
- Posted
- August 3, 2005
- Terminated
- November 17, 2005
- Recall Number
- Z-1064-05
- Quantity
- 13
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
Distribution
CA, IL, MI, MO, OR and PA
Lot / Code Info
263958, 264039, 264055, 264058, 264059, 264060, 264064, 264066, 264069, 264070, 264112, 264117 and 264119
Root Cause
Other
Action Taken
Sales Representatives notified 06/16/05 to return devices in their area.
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