Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 50 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 (risk-of-harm product). The source text does not report any 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 50 units of BD PosiFlush SF Saline Flush Syringes (10 mL) used in the POWERWAND XL 5Fr 10cm Quick Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.
The affected products are identified by lot numbers 263650 and 268325. These syringes are 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 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. Users should stop using the affected syringes and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - 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 me
- Manufacturer
- Access Scientific LLC
- Category
- Medical Device — Syringes
- Affected units
- 50
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 (2)
- LOTS: 263650
- 268325
Distribution
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
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- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
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