Device product
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Z-2889-2016
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 74901
- Status
- Terminated
- Classification
- Class II
- Quantity
- 396,024 eaches
- Official record key
device-enforcement:Z-2889-2016
Official wording
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 information: 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 pattern: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
Derived failure modes
-
Unknown
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.