Device product
Flexible Intubation Fiberscope, Model # 11301AB1
Z-2447-2019
Product summary
- Event
- Event 83419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 scopes
- Official record key
device-enforcement:Z-2447-2019
Official wording
Reason: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
Code information: Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769
Distribution pattern: US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
Derived failure modes
-
Unknown
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.