Recall Z-1404-2015 ยท KDQ Bottle, Collection, Vacuum
Teleflex Medical
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
| Date | Apr 8, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system. |
| Root cause | Other |
| Action | Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected listed catalog numbers and to return the product. Complete the enclosed acknowledgement form to Teleflex Medical. The form is to be returned even if they have not products. For further questions contact your local sales representative or Customer Service at 1-866 246-6990. |
| Quantity | 2,148 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR Deknatel, Inc., Aug 28, 1996 |