FDAClass IIFebruary 26, 2025

3M V.A.C. VIA Negative Pressure Wound Therapy System recall

3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack…

Why was 3M V.A.C. VIA Negative Pressure Wound Therapy System recalled?

Due to increase in complaints related to leak alarms

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

VIAKIT077D01/US V.A.C. VIA 7 DAY KIT UDI-DI code: 00849554002388 Assembly Item Number: VIAKIT077D01/USV003 Lot Numbers: C17525V003 C17557V003 VIAKIT07S05/AU V.A.C. VIA STARTER KIT 5-PACK UDI-DI code: 00849554002401 Assembly Item Number: VIAKIT07S05/AUV003 Lot Number: C16937V003 VIAKIT077D01/GB V.A.C. VIA 7 DAY KIT, SINGLE SHIPPER UDI-DI code: 00849554002364 Assembly Item Number: VIAKIT077D01/GBV003 Lot Numbers: C16936V003 C17027V003

Product
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack…
Recalling firm
KCI USA, INC.
Quantity
2,169
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.
Recall date
February 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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