Recall Z-1889-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Ethicon Endo-Surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
| Date | May 15, 2019 |
| Status | Terminated |
| Reason | Observed reported incidence rate for harm associated with intraoperative bleeding |
| Root cause | Under Investigation by firm |
| Action | Ethicon issued Urgent Medical Device recall letter dated May 15, 2019 advising of product problem, health risk, and action to take: determine if you have product subject to this recall (removal) on hand and quarantine such product(s); 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a c |
| Quantity | 1059 boxes |
| Distribution | Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172580 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, EN Ethicon Endo-Surgery, LLC, Nov 20, 2017 |