FDA Device

V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.

Hazard

Possible mislabeling of shipping cartons.

What You Should Do

Remedy

All hospitals and nursing homes contacted via letter and by phone.

Products

V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
Brand
Kinetic Concepts, Inc
UPC
Lot #08150506M

Units Affected

64 cartons.