🔍 RecallPedia

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - 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.

Class I - Dangerous
🏥 Medical Devices Recalled: April 23, 2020 Access Scientific Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    LOTS: 257862, 260252, 261065, 262162, 263385, 264339, 267088, 268940, 268942, 269086, 269334, 269340, 270250, 270777
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Access Scientific LLC
Reason for Recall:
Saline Flush Syringe compromised sterility due to holes in the packaging.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - 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.

Product Codes/Lot Numbers:

LOTS: 257862, 260252, 261065, 262162, 263385, 264339, 267088, 268940, 268942, 269086, 269334, 269340, 270250, 270777

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1975-2020

Related Recalls

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.

Access Scientific

Class I - Dangerous

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.

Jun 15, 2020 Surgical Instruments Nationwide View Details →

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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.

Access Scientific

Class I - Dangerous

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

Apr 23, 2020 Surgical Instruments Nationwide View Details →

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - 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.

Access Scientific

Class I - Dangerous

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

Apr 23, 2020 Surgical Instruments Nationwide View Details →