FDA recall Z-1193-2018

Teleflex Medical · Class II · device

Product

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

Reason for recall

Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

Distribution

KS

Key facts

Status
Terminated
Initiation date
2018-02-15
Report date
2018-04-04
Termination date
2018-10-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1193-2018