FDA recall Z-1889-2019
Ethicon Endo-Surgery Inc · Class II · device
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Reason for recall
Observed reported incidence rate for harm associated with intraoperative bleeding
Distribution
Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Key facts
- Status
- Terminated
- Initiation date
- 2019-05-15
- Report date
- 2019-07-03
- Termination date
- 2020-06-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Blue Ash, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1889-2019