Z-1890-2019 Class II Terminated
FDA device recall Z-1890-2019 was initiated by Ethicon Endo-Surgery Inc on May 15, 2019 and is designated Class II. Reason for recall: Observed reported incidence rate for harm associated with intraoperative bleeding The recall status is terminated (terminated June 11, 2020). Affected quantity: 308 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- May 15, 2019
- Termination Date
- June 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 308 boxes
Product Description
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
Reason for Recall
Observed reported incidence rate for harm associated with intraoperative bleeding
Distribution Pattern
Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Code Information
All lot numbers