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.
FDA Recall Z-1130-2007 · Posted 2007-08-07
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Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-05-18
Date Terminated2011-08-22
Product Quantity67,625 units
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.
Firm Action
Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Canada and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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