Device product
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Z-1190-2014
Product summary
- Event
- Event 66837
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1190-2014
Official wording
Reason: issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Code information: 2483968 2492596 2496746 2500736 2505477 2514016 2524048 2529356 2536681 2541173 2554034 2475168
Distribution pattern: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
Derived failure modes
-
Unknown
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes