Home / Recalls / Access Scientific LLC / Z-1979-2020

Z-1979-2020 Class II Terminated

Recalled by Access Scientific LLC — San Diego, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
April 23, 2020
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
570 units

Product Description

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - 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.

Reason for Recall

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

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.

Code Information

LOTS:269939, 270552, 270874

Other recalls by Access Scientific LLC

  • Z-2550-2020 Class III — POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Cath (June 15, 2020)
  • Z-1980-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Ki (April 23, 2020)
  • Z-1978-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Ki (April 23, 2020)
  • Z-1976-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barr (April 23, 2020)
  • Z-1972-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6 (April 23, 2020)
  • Z-1977-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Bar (April 23, 2020)
  • Z-1974-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Ki (April 23, 2020)
  • Z-1981-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatri (April 23, 2020)
  • Z-1973-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site K (April 23, 2020)
  • Z-1983-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barr (April 23, 2020)