Z-2447-2019 Class II Terminated
FDA device recall Z-2447-2019 was initiated by Karl Storz Endoscopy on April 24, 2019 and is designated Class II. Reason for recall: The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer. The recall status is terminated (terminated December 4, 2020). Affected quantity: 14 scopes.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- April 24, 2019
- Termination Date
- December 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 scopes
Product Description
Flexible Intubation Fiberscope, Model # 11301AB1
Reason for Recall
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
Distribution Pattern
US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
Code Information
Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769