Z-1741-2018 Class II Terminated
FDA device recall Z-1741-2018 was initiated by Microline Surgical, Inc. on November 1, 2017 and is designated Class II. Reason for recall: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. The recall status is terminated (terminated September 17, 2019). Affected quantity: 4 boxes of 10 tips each.
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- November 1, 2017
- Termination Date
- September 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 boxes of 10 tips each
Product Description
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.
Reason for Recall
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Distribution Pattern
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Code Information
Lot Numbers: 70211 UDI: 00811099012115