FDA recall Z-0861-2020

Vitreq Bv · Class II · device

Product

VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669

Reason for recall

Microscopic tears of the sterile pouch may compromise sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-12-17
Report date
2020-02-05
Termination date
2020-12-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vierpolders, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2020