ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
This recall has been terminated (originally issued November 1, 2017).
- Company
- Microline Surgical, Inc.
- Recall Initiated
- November 1, 2017
- Terminated
- September 17, 2019
- Recall Number
- Z-1741-2018
- Quantity
- 4 boxes of 10 tips each
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Distribution
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Lot / Code Info
Lot Numbers: 70211 UDI: 00811099012115
Root Cause
Process control
Action Taken
Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to suggest that the sterile barrier provided by the sealed pouches were damaged because of the rework, but are initiating this recall out of an abundance of caution because if a sterile barrier was compromised, there is potential that use of the device could result in an infection. If you experience any adverse events or quality problems with the use of this product, you should report this to FDAs MedWatch Adverse Event Reporting Program and to Microline as soon as possible. All product returned will be replaced at no cost. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or inf o@m icr olinesur g ical.com. with any further questions. For further questions, please call (978) 867-1758.