RecallRadar

FDA Device recall Z-0490-2018

Hemofiltration Standard Pack including BC 60 Plus-T 8036

On 2018-02-07 the FDA classified a Class II recall of Hemofiltration Standard Pack including BC 60 Plus-T 8036 by Maquet, citing 55 kits were distributed after their expiration date of September 2015.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0490-2018
ClassificationClass II
Statusterminated
Initiated2017-05-22
Published2018-02-07
Last updated2026-09-13 11:54 UTC
CompanyMaquet
DistributionCA, IL, NM

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

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

Identifiers

code_infoLot/batch number: 3000001571 UDI code: 607567206489

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.