Recall Z-2433-2019 ยท BSF Absorber, Carbon-Dioxide
GETINGE US SALES LLC
Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.
| Date | Jul 22, 2019 |
| Status | Terminated |
| Reason | Reversed expiration and manufacturing date on the label |
| 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 |
| Quantity | 1444 boxes worldwide |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.