FDA recall Z-1012-2019

Product

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220

Reason for recall

The sterile barrier may contain packaging seal defects.

Distribution

The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.

Key facts

Status

Terminated

Initiation date

2018-12-26

Report date

2019-03-20

Termination date

2020-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2019