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Getinge MCC Flow i Disposable CO2 absorber, used in… recallZ-2433-2019 · Getinge US Sales LLC · initiated Jul 22, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge US Sales LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Reversed expiration and manufacturing date on the label

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number
Z-2433-2019
Status
Terminated
Initiated by the company
Jul 22, 2019
Recalling firm
Getinge US Sales LLC
Quantity
1444 boxes worldwide
Product code
BSF
Distribution
US nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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