Z-2433-2019 Class II Terminated

Recalled by GETINGE US SALES LLC — WAYNE, NJ

FDA device recall Z-2433-2019 was initiated by GETINGE US SALES LLC on July 22, 2019 and is designated Class II. Reason for recall: Reversed expiration and manufacturing date on the label The recall status is terminated (terminated May 26, 2020). Affected quantity: 1444 boxes worldwide.

Recall Details

Product Type
Devices
Report Date
September 11, 2019
Initiation Date
July 22, 2019
Termination Date
May 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1444 boxes worldwide

Product Description

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Reason for Recall

Reversed expiration and manufacturing date on the label

Distribution Pattern

US nationwide distribution.

Code Information

Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988