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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge MCC Flow i Disposable CO2 absorber

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 Class 2 Device Recall Getinge MCC Flow i Disposable CO2 absorbersee related information
Date Initiated by FirmJuly 22, 2019
Create DateAugust 30, 2019
Recall Status1 Terminated 3 on May 26, 2020
Recall NumberZ-2433-2019
Recall Event ID 83468
Product Classification Absorber, carbon-dioxide - Product Code BSF
ProductGetinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
Code Information Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988
FEI Number 3012092534
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 BARBOUR POND DR
WAYNE NJ 07470
For Additional Information ContactRachana Patel
973-709-7412
Manufacturer Reason
for Recall		Reversed expiration and manufacturing date on the label
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm 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).
Quantity in Commerce1444 boxes worldwide
DistributionUS nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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