Recall Z-1212-2019 ยท HDA Forceps, Obstetrical
COVIDIEN LLC
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures.
| Date | Mar 13, 2019 |
| Status | Terminated |
| Reason | Sterilization method used was not consistent with the labeling and the approved sterilization method |
| Root cause | Process control |
| Action | Medtronic notified consignees via an "URGENT MEDICAL DEVICE RECALL" letter by Federal Express and/or certified mail on March 13, 2019. The letter informs customers of the recall of twenty-one production lot of Covidien Endo Clinch" and Endo Grasp" Auto Suture" graspers 5mm as the sterilization method used for these lots was not consistent with the labeling and the approved sterilization method. Customers are instructed to take the following actions: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed above. 2. Please return affected product as indic |
| Quantity | 240 units |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP United States Surgical, A Division of Tyco Healthc, Oct 11, 1990 |