Z-2433-2019Class II
Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems
Getinge US Sales LLC / initiated 2019-07-22 / Terminated / root cause: labeling and UDI
GETINGE US SALES LLC began a recall of Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems on . FDA classified it as Class II and gives the reason as "Reversed expiration and manufacturing date on the label". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2433-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Getinge US Sales LLC
- Product
- Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
- Product code
- BSF Absorber, Carbon-Dioxide
- Reason for recall
- Reversed expiration and manufacturing date on the label
- Root cause tag
- labeling and UDI
- FDA root cause
- 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. 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.
- Product codes and lots
- Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2433-2019 | Class II | Terminated | Voluntary: Firm initiated |
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