Recalls / —
—#173260
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K172580
- Affected lot / code info
- All lot numbers
Why it was recalled
Observed reported incidence rate for harm associated with intraoperative bleeding
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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 copy of this recall (removal) letter when communicating. 4. Complete the Business Reply Form (BRF) 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return unused impacted ENSEAL X1 Curved Jaw Tissue Sealer in their inventory immediately. Questions customer complaints contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Recalling firm
- Firm
- Ethicon Endo-Surgery Inc
- Address
- 4545 Creek Rd, Blue Ash, Ohio 45242-2803
Distribution
- Distribution pattern
- Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Timeline
- Recall initiated
- 2019-05-15
- Terminated
- 2020-06-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173260. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.