The Recall Desk
HighFDA (Devices)·Z-1973-2020·Announced 2020-05-20

Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Holes

Access Scientific LLC is recalling 6,254 units of BD PosiFlush SF Saline Flush Syringes 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 illnesses or injuries, 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 6,254 units of BD PosiFlush SF Saline Flush Syringe 10 mL used in the POWERWAND"XL Alternate Site Kit, 4Fr. The recall was initiated because holes in the packaging compromised the sterility of the syringes.

The affected products are 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. The specific lot numbers involved are 259489, 259956, 261313, 262479, 263893, 265955, 266809, 267719, and 268776.

These syringes are used to gain access to the vascular system to sample blood and administer fluids intravenously. They may also be used for power injection of contrast media. Consumers and healthcare providers should stop using the affected syringes and contact the recalling firm for further instructions.

The recalled product

Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - 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 contras
Manufacturer
Access Scientific LLC
Category
Medical Device — Syringes
Hazard
Affected units
6,254

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: 259489
  • 259956
  • 261313
  • 262479
  • 263893
  • 265955
  • 266809
  • 267719
  • 268776

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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