Recall Z-1213-2019 ยท HDA Forceps, Obstetrical
COVIDIEN LLC
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6)BOX PST01134 LAP CHOLE KIT ST JOHN S (7)KIT00599 LAPARO GENERICO X1 (8)KIT00608 APENDICECTOMIA LAP X1 (9)KIT2176CV BORNHOL
| 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 | 148 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 |