FDA-Device2015-04-15Class II

Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

Teleflex Medical
Hazard

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

Sold states
US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.
Affected count
2,148 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1404-2015

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