RecallDepth

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

Company
Getinge Us Sales Llc
Recall Initiated
July 22, 2019
Terminated
May 26, 2020
Recall Number
Z-2433-2019
Quantity
1444 boxes worldwide
Firm Location
WAYNE, NJ

Reason for Recall

Reversed expiration and manufacturing date on the label

Distribution

US nationwide distribution.

Lot / Code Info

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

Root Cause

Under Investigation by firm

Action Taken

Firm issued letter 7/22/2019. 1. Examine your inventory immediately to determine if you have a FLOWi DISPOSABLE CO2 ABSORBER with the product lot numbers 2. Affected product should be returned to Getinge 3. Please complete the Urgent Medical Device Recall Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall Removal letter. 4. Please fax or email the completed form to Getinge office as instructed on the form. 5.Please contact Getinge Customer Service at 18886278383 (press option 2, then option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return authorization (RMA) and shipping instructions to return any affected product. If you have any questions, please contact Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

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