Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation dur

FDA device recall Z-0490-2018 · posted 2017-12-20 · Terminated

Recall details

Recalling firm

Maquet

Reason for recall

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

Action taken

Medical Device Recall (Removal) Notices were sent to customers via FedEx on 5/22/2017. The letters identified the affected device and the issue. Users are asked to examine their inventory to determine if any of the affected product is on hand. If found, affected devices should be removed and quarantined. Customers should contact Maquet/Getinge Customer Support at 1-888-627-8383 to obtain instructions on returning the affected devices. The Medical Device Recall Removal Response Form provided should be completed and returned. Questions should be directed to your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 1-888-627-8383.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

DWE

Quantity affected

55 units

Distribution

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

Date initiated

2017-05-22

Date posted

2017-12-20

Date terminated

2018-07-12

Location

Fairfield, NJ

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