Recall Z-0490-2018— Maquet

Name: FDA recall Z-0490-2018
Creator: U.S. Food and Drug Administration
Published: 2017-05-22

Class II · Terminated

Class II FDA medical device recall by Maquet, initiated 2017-05-22, terminated 2018-07-12. It names one FDA 510(k) clearance: K053025. 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..

Recalling firm: Maquet
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Terminated: 2018-07-12
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K053025 — JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AG·cleared 2005-11-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.