Device product
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Z-2496-2019
Product summary
- Event
- Event 83637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 unit of Lot 837B
- Official record key
device-enforcement:Z-2496-2019
Official wording
Reason: possibility of the sterility batch being insufficiently sterilized
Code information: Lot # 109C and 837B
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
possibility of the sterility batch being insufficiently sterilized