The Recall Desk
HighFDA (Devices)·Z-1983-2020·Announced 2020-05-20

Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes

Access Scientific LLC is recalling 110 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 (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 110 units of BD PosiFlush SF Saline Flush Syringes (10 mL) used in the POWERWAND XL 5Fr 8cm Max Barrier Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.

The affected product is identified by Lot 267011 and REF/UDI 94116/10859821006237. 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.

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. Consumers and healthcare providers should stop using the affected syringes and contact Access Scientific LLC for further instructions.

The recalled product

Product
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 contra
Affected units
110

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 (1)

  • LOTS: 267011

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 →