Device product
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Z-1583-2018
Product summary
- Event
- Event 79939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1800 pencils
- Official record key
device-enforcement:Z-1583-2018
Official wording
Reason: Non-sterile product was packaged inside a case that was labeled as sterile.
Code information: Lot Number 44210051
Distribution pattern: Honduras, Belgium, and The Netherlands
Derived failure modes
-
Sterility assurance
Non-sterile product was packaged inside a case that was labeled as sterile