Teleflex Medical recalls Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usa…

Recall date

March 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1582-2016

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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