FDA recall Z-2550-2018

Product

Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

Reason for recall

Kit was labeled with the incorrect Expiration Date of April 30, 2019.

Distribution

US state of FL

Key facts

Status

Terminated

Initiation date

2017-05-12

Report date

2018-08-01

Termination date

2018-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ashland, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2018