The Recall Desk
HighFDA (Devices)·Z-1980-2020·Announced 2020-05-20

Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

Access Scientific LLC is recalling 4,187 saline flush syringes used in vascular 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 presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Access Scientific LLC is recalling 4,187 units of BD PosiFlush SF Saline Flush Syringe 10 mL, which are used in the POWERWAND XL 3Fr 6cm Quick Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.

The affected products were 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 257866, 259929, 260815, 260982, 264749, 267192, 267193, and 269120.

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. Users should check their inventory for the listed lot numbers and stop using any affected units.

The recalled product

Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - 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 med
Manufacturer
Access Scientific LLC
Category
Medical Device — Syringes
Hazard
Affected units
4,187

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 (8)

  • LOTS:257866
  • 259929
  • 260815
  • 260982
  • 264749
  • 267192
  • 267193
  • 269120

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

See all →

Same hazard · sterility compromise

See all →