Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
This recall has been terminated (originally issued August 7, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- May 18, 2007
- Posted
- August 7, 2007
- Terminated
- August 22, 2011
- Recall Number
- Z-1130-2007
- Quantity
- 67,625 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
Distribution
Worldwide, including USA, Canada and France.
Lot / Code Info
No manufacturing or serial numbers.
Root Cause
Other
Action Taken
Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.
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