Date Initiated by Firm |
July 22, 2019 |
Create Date |
August 30, 2019 |
Recall Status1 |
Terminated 3 on May 26, 2020 |
Recall Number |
Z-2433-2019 |
Recall Event ID |
83468 |
Product Classification |
Absorber, carbon-dioxide - Product Code BSF
|
Product |
Getinge 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 |
Recalling Firm/ Manufacturer |
GETINGE US SALES LLC 45 BARBOUR POND DR WAYNE NJ 07470
|
For Additional Information Contact |
Rachana Patel 973-709-7412
|
Manufacturer Reason for Recall |
Reversed expiration and manufacturing date on the label
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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.
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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 Commerce |
1444 boxes worldwide |
Distribution |
US nationwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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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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