—#170889

Product

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

FDA product code: FQH — Lavage, Jet
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K983135
Affected lot / code info: Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Why it was recalled

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Root cause (FDA determination)

Employee error

Action the firm took

The firm, Maquet/Getinge, issued "URGENT MEDICAL DEVICE RECALL - REMOVAL" letters mailed to customers on January 24, 2019 via FedEx Priority Overnight,. The letters identified the issue, the product, actions to take and health risk. The customers were instructed to:Please examine your inventory immediately to determine if you have any of the affected; stop using the affected lot numbers of the Axius Blower Mister; remove and properly label any identified affected product, and keep it in quarantine in a secure location to preclude being used. Should you have un-used affected product you are eligible for either a replacement or credit. Please contact Geting Customer Service at 1-888-627-8383 (press option 2, then option 4) to request a return authorization (RMA) and shipping instructions to return any affected product. Complete and sign the MEDICAL DEVICE RECALL - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to blowermister(@qetinge.com or by faxing the form to 1-800-915-0124. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 4), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

Timeline

Recall initiated: 2019-01-24
Terminated: 2020-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170889. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.