FDA recall Z-0490-2018

Product

Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.

Reason for recall

55 kits were distributed after their expiration date of September 2015.

Distribution

Distributed to the states of NM, CA, and IL.

Key facts

Status

Terminated

Initiation date

2017-05-22

Report date

2018-02-07

Termination date

2018-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2018