Recall Z-1582-2016 ยท CAC Apparatus, Autotransfusion
Teleflex Medical
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
| Date | Mar 30, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| 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 recalls@teleflex.com.. For questions contact your local sales representative or Customer Service at 1-866-246-6990. |
| Quantity | 12,124 ea. |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflexmedical, Inc., Oct 23, 2014 |