FDA Enforcement
Class II
Terminated
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Recall: Z-2889-2016
·
Reported October 5, 2016
Enforcement
- Recall Number
- Z-2889-2016
- Event ID
- 74901
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ethicon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 5, 2016
- Initiation Date
- August 1, 2016
- Classification Date
- September 27, 2016
- Termination Date
- November 29, 2017
- Address
- US Highway 22 West, N/A, Somerville, NJ, 08876, United States
Description
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Reason
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.
Code Info
All unexpired lots MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212
Distribution
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
Quantity
396,024 eaches