Device product
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Z-1404-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,148 units
- Official record key
device-enforcement:Z-1404-2015
Official wording
Reason: Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.
Code information: Catalogue no. S-1100-08LF, Lot no. 74F1400878
Distribution pattern: 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.
Derived failure modes
-
Unknown
Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.