FDA-Device2016-05-04Class II
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Teleflex Medical
Hazard
The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Sold states
Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
Affected count
12,124 ea.
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2016Don't want to check this manually?
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