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.
FDA Recall Z-0490-2018 · Posted 2017-12-20
Advertisement
Recalling FirmMaquet
Recall StatusTerminated
Product CodeDWE
Date Initiated2017-05-22
Date Terminated2018-07-12
Product Quantity55 units
Reason for Recall
55 kits were distributed after their expiration date of September 2015.
Firm Action
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
Distribution Pattern
Distributed to the states of NM, CA, and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement