FDA recall Z-2947-2018

Product

CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

Reason for recall

The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

Distribution

United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

Key facts

Status

Terminated

Initiation date

2018-07-30

Report date

2018-09-05

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kalona, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2947-2018