Device product
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Z-1892-2018
Product summary
- Firm
- Southmedic, Inc.
- Event
- Event 80074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,300 scalpels
- Official record key
device-enforcement:Z-1892-2018
Official wording
Reason: Scalpels lot contains non-sterile products labeled as sterile.
Code information: Part Number 73-0115 Lot Number 092517
Distribution pattern: US Distribution to the states of : IA, IL, NE, NY and TX
Derived failure modes
-
Sterility assurance
non-sterile products labeled as sterile