FDA recall Z-2764-2017

Product

DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

Reason for recall

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Distribution

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.

Key facts

Status

Terminated

Initiation date

2017-06-22

Report date

2017-08-02

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2764-2017