PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethy
FDA device recall Z-1064-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Guidant Corporation
- Reason for recall
- Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.
- Action taken
- Sales Representatives notified 06/16/05 to return devices in their area.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRG
- Quantity affected
- 13
- Distribution
- CA, IL, MI, MO, OR and PA
- Date initiated
- 2005-06-16
- Date posted
- 2005-08-03
- Date terminated
- 2005-11-17
- Location
- Saint Paul, MN
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