Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
This recall has been terminated (originally issued April 8, 2015).
- Company
- Teleflex Medical
- Recall Initiated
- March 13, 2015
- Posted
- April 8, 2015
- Terminated
- August 14, 2017
- Recall Number
- Z-1404-2015
- Quantity
- 2,148 units
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
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.
Lot / Code Info
Catalogue no. S-1100-08LF, Lot no. 74F1400878
Root Cause
Other
Action Taken
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.