The Recall Desk
HighFDA (Devices)·Z-1976-2020·Announced 2020-05-20

Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects

Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL kits because holes in the packaging compromised sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with compromised sterility, which poses a risk of infection or harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes (10 mL) that are used in the POWERWAND XL 4Fr 8cm Max Barrier Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes. The affected product is used to gain access to the vascular system to sample blood and administer fluids intravenously, and may be used for power injection of contrast media.

The recall covers specific lots: 259731, 261932, 263922, 267010, 268210, 269118, 269714, 270347, and 270778. The product was distributed nationwide in the United States, 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, and UT.

Healthcare providers and consumers should stop using the affected syringes and contact Access Scientific LLC for further instructions or a replacement.

The recalled product

Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - 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 contra
Manufacturer
Access Scientific LLC
Category
Medical Device — Syringes
Hazard
Affected units
1,864

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • LOTS: 259731
  • 261932
  • 263922
  • 267010
  • 268210
  • 269118
  • 269714
  • 270347
  • 270778

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Access Scientific LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Access Scientific LLC

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Same hazard · sterility compromise

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