LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.
This recall has been terminated (originally issued June 28, 2011).
- Recall Initiated
- December 1, 2009
- Posted
- June 28, 2011
- Terminated
- February 23, 2012
- Recall Number
- Z-2690-2011
- Quantity
- 1,950 pieces
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the LiNA Loop to break during operating procedure.
Distribution
GA, MN, PA, WA, TN, MA, IN, Ontario Canada
Lot / Code Info
Batch 9435, 9422, 9404, 9462, 9451, 9452, 9442, 9371, 9343, 9131, 9471, 7282, 8284, 8285, 8411, 8395, and 8442
Root Cause
Labeling design
Action Taken
Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.