Device product
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Z-1716-2020
Product summary
- Event
- Event 84681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 127,700 total devices
- Official record key
device-enforcement:Z-1716-2020
Official wording
Reason: Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Code information: Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727
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
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.