FDA-Device2015-03-11Class II

KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

Halyard Health
Hazard

Defect: A hole or crack was found which may cause air to leak.

Sold states
CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Affected count
83 cases (20 tubes per case)
Manufactured in
1400 Holcomb Bridge Rd, N/A, Roswell, GA, United States
Products
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2015

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