Home / Recalls / Access Scientific LLC / Z-2550-2020

Z-2550-2020 Class III Terminated

Recalled by Access Scientific LLC — San Diego, CA

Recall Details

Product Type
Devices
Report Date
July 22, 2020
Initiation Date
June 15, 2020
Termination Date
October 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1710

Product Description

POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.

Reason for Recall

Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.

Distribution Pattern

US Nationwide distribution including in the state of NY.

Code Information

Lot number 269939, 270552, 270874, and 272261.

Other recalls by Access Scientific LLC

  • Z-1975-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick K (April 23, 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-1982-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick K (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)