—#171603

Product

Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

FDA product code: HDA — Forceps, Obstetrical
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K903205
Affected lot / code info: Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX

Why it was recalled

Sterilization method used was not consistent with the labeling and the approved sterilization method

Root cause (FDA determination)

Process control

Action the firm took

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 indicated below. 3. If you have distributed the Endo Clinch" II or Endo Grasp" Auto Suture" graspers 5mm listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. -----If you have inventory email to: feedback.customerservice@covidien.com fax to: 800-895-6140. -----Exception: Customers with zero inventory, fax to 203-492-7719 or email to GMBFCAMITG@Medtronic.com If purchased by distributor, fax to 203-492-7719 or email GMBFCAMITG@Medtronic.com. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

Recalling firm

Firm: COVIDIEN LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

Timeline

Recall initiated: 2019-03-13
Terminated: 2020-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.