Recall Z-2889-2016— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2016-08-01, terminated 2017-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-01
- Terminated
- 2017-11-29
- Firm location
- Somerville, NJ, United States
Product description
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.