Recall Z-2622-2017 ยท GCJ Laparoscope, General & Plastic Surgery
Covidien LLC
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | Cotton tip of the device may disengage due to insufficient adhesive |
| Root cause | Process control |
| Action | Medtronic consignees were notified via Federal Express or certified mail on May 9, 2017, and the letter informs customers of the potential for the tip of the device to disengage from the device and the actions they should take. Accounts requested to discontinue use, quarantine and return product. Customers are requested to complete and acknowledge receipt of the Urgent Field Corrective Action Notice. Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. For questions regarding this recall call 203-492-5000. |
| Quantity | 194,851 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931962 | NON-ABSORBABLE GAUZE United States Surgical, A Division of Tyco Healthc, Dec 10, 1993 |