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
FDA Recall Z-1582-2016 · Posted None
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCAC
Date Initiated2016-03-30
Date Terminated2025-01-30
Product Quantity12,124 ea.
Reason for Recall
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.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notification dated March 30, 2016 to customers and distributors. The letter identified the affected product, problem and actions to be taken. The letter requested that they discontinue use and quarantine any products. The letter instructed customers to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Error in labeling
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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