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Recall Observatory FDA recall evidence

Device product

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

Z-1972-2020

April 23, 2020

Class II

Product summary

Firm
Access Scientific LLC
Event
Event 85586
Status
Terminated
Classification
Class II
Quantity
2697 units
Official record key
device-enforcement:Z-1972-2020

Official wording

Reason: Saline Flush Syringe compromised sterility due to holes in the packaging.

Code information: LOT: 257828, 258294, 259262, 260814, 260173, 261861, 264561, 266804, 266805, 267191, 269121

Distribution pattern: US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterility