Device product
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Z-1715-2020
Product summary
- Event
- Event 84681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720,100 total devices
- Official record key
device-enforcement:Z-1715-2020
Official wording
Reason: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Code information: Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747
Distribution pattern: USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.
Derived failure modes
-
Unknown
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.